Graham, Janice
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Item Open Access Just Evidence: Opening Health Knowledge to a Parliament of Evidence(CRC Press / Taylor & Francis Group, 2016) Graham, Janice; Jones, MavisIn this chapter, we present a complementary perspective to the oceans theme of this volume by ethnographically engaging the circulation of scientific knowledge and evidence in a different but comparable policy decision-making environment. We will use two case studies in health regulation that explore: (i) national regulatory practices and policies for emerging health products, and (ii) global vaccine development and implementation platforms. These case studies and the conclusions that we draw illustrate the role(s) information plays in decision-making processes at the science-policy interface in regulatory contexts that parallels the observations and conclusions of the authors of other chapters in this book.Item Open Access Faster access to new drugs: Fault lines between Health Canada’s regulatory intent and Industry innovation practices(Begell House, 2013) Graham, Janice; Nuttall, RobertSince 2003, Health Canada has been undergoing regulatory modernization to “ensure that Canadians have faster access to the safe drugs they need.” As national health agencies develop policies to modernize the regulation of new drugs, we examined a decade of drug approval data from the Canadian setting to see whether these policies promote innovation while maintaining safety. The drug approval data in Health Canada’s Annual Drug Submission reports between 2000 and 2010 were analysed to determine the proportion of new active substances qualifying as innovative new drugs. We also examined the proportion of successful submissions granted priority review that subsequently received safety warnings. We show that despite an increase in supplementary product submissions, there was no sustained increase in new active pharmaceutical or biologic products. Furthermore, priority reviews are intended to expedite new drug submissions that promise significant clinical benefits. While the proportion of submissions indicated for new active substances declined, there was a significantly higher rate of safety warnings for their priority reviews. Our results challenge the assumption that the new regulatory policies that were intended to spur industry innovation of new and safer drugs work.Item Open Access Risks of nutrigenomics and nutrigenetics? What the scientists say.(BMC Springer Nature, 2013-11-29) Hurlimann, Thierry; Menuz, Vincent; Graham, Janice; Robitaille, Julie; Vohl, Marie-Claude; Godard, BéatriceNutrigenomics and nutrigenetics (hereafter NGx) have stimulated expectations for beneficial applications in public health and individuals. Yet, the potential achievability of such promise is not without socioethical considerations that challenge NGx implementation. This paper focuses on the opinions of NGx researchers about potential risks raised by NGx. The results of an online survey show that these researchers (n = 126) are fairly confident about the potential benefits of NGx, and that most downplay its potential risks. Researchers in this field do not believe that NGx will reconfigure foods as medication or transform the conception of eating into a health hazard. The majority think that NGx will produce no added burden on individuals to get tested or to remain compliant with NGx recommendations, nor that NGx will threaten indi- vidual autonomy in daily food choice. The majority of researchers do not think that NGx will lead to discrimination against and/or stigmatization of people who do not comply with NGx dietary recommendations. Despite this optimism among NGx researchers, we suggest that key risk factors raised by the socioethical context in which NGx applications will be implemented need to be considered.Item Open Access Exploring the post-genomic world: differing explanatory and manipulatory functions of post-genomic sciences(Taylor & Francis, 2016-02-25) Holmes, Christina; Carlson, Siobhan; McDonald, Fiona; Jones, Mavis; Graham, JaniceRichard Lewontin proposed that the ability of a scientific field to create a narrative for public understanding garners it social relevance. This article applies Lewontin’s conceptual framework of the functions of science (manipulatory and explanatory) to compare and explain the current differences in perceived societal relevance of genetics/genomics and proteomics. We provide three examples to illustrate the social relevance and strong cultural narrative of genetics/genomics for which no counterpart exists for proteomics. We argue that the major difference between genetics/ genomics and proteomics is that genomics has a strong explanatory function, due to the strong cultural narrative of heredity. Based on qualitative interviews and observations of proteomics conferences, we suggest that the nature of proteins, lack of public understanding, and theoretical complexity exacerbates this difference for proteomics. Lewontin’s framework suggests that social scientists may find that omics sciences affect social relations in different ways than past analyses of genetics.Item Open Access Ambiguous Capture: Collaborative Capitalism and the Meningitis Vaccine Project(Taylor & Francis Group, 2016-04-21) Graham, JaniceThe primary health care approach advanced at Alma Ata to address social determinants of health was replaced by selective health care a year later at Bellagio. Subsequently, immunization was endorsed as a cost-effective technical intervention to combat targeted infectious diseases. Multilateral efforts to collaborate on immunization as a universal public health good ambiguously capture the interests of the world’s governments as well as private, public, and not-for-profit institutions. Global assemblages of scien- tists, governments, industry and nongovernmental organizations now work in public-private partnerships to develop and make essential vaccines accessible, with vaccines marketed as single fix solutions for global health. Drawing from ethnographic fieldwork in France and Burkina Faso that followed the development, regulation, and implementation of the group A meningococcal conjugate vaccine for sub-Saharan Africa, in this article I describe events during and after the development of MenAfriVac. A tech- nological success narrative steeped in collaborative capitalist rhetoric dis- guises neglected health care systems.Item Open Access Understanding vaccine hesitancy in Canada: Results of a consultation study by the Canadian Immunization Research Network(Public Library of Science, 2016-06-03) Dubé, Eve; Gagnon, Dominique; Ouakki, Manale; Bettinger, Julie; Guay, Maryse; Halperin, Scott; Wilson, Kumanan; Graham, Janice; Witteman, Holly; MacDonald, Shannon; Fisher, William; Monnais, Laurence; Tran, Dat; Gagneur, Arnaud; Guichon, Juliet; Saini, Vineet; Heffernan, Jane; Meyer, Samantha; Driedger, S. Michelle; Greenberg, Joshua; MacDougall, Heather“Vaccine hesitancy” is a concept now frequently used in vaccination discourse. The increased popularity of this concept in both academic and public health circles is challenging previously held perspectives that individual vaccination attitudes and behaviours are a simple dichotomy of accept or reject. A consultation study was designed to assess the opin- ions of experts and health professionals concerning the definition, scope, and causes of vaccine hesitancy in Canada. We sent online surveys to two panels (1- vaccination experts and 2- front-line vaccine providers). Two questionnaires were completed by each panel, with data from the first questionnaire informing the development of questions for the second. Our participants defined vaccine hesitancy as an attitude (doubts, concerns) as well as a behaviour (refusing some / many vaccines, delaying vaccination). Our findings also indicate that both vaccine experts and front-line vaccine providers have the perception that vaccine rates have been declining and consider vaccine hesitancy an important issue to address in Canada. Diffusion of negative information online and lack of knowledge about vaccines were identified as the key causes of vaccine hesitancy by the participants. A common understanding of vaccine hesitancy among researchers, public health experts, policy- makers and health care providers will better guide interventions that can more effectively address vaccine hesitancy within Canada.Item Open Access Lueurs et leurres de la santé globale À propos de MenAfriVac®, un vaccin « africain » contre la méningite(Open Edition Journals, 2017-12) Thiongane, Oumy; Graham, Janice; Broutin, HélèneIn biomedical narratives, the Meningitis Vaccine Project (MVP) enabled the technology transfer for the development and implementation of MenAfriVac® vaccine at an affordable price for African countries. The presentation of MVP as a success story, however, may be more sociotechnical myth than fact. MenAfriVac® is far from being a silver bullet . While successful in eliminating Meningitis A, MVP rhetoric highlighting meningitis control obscured a more complex epidemiological context. This paper analyzes the discursive construction of success that supports global health single vaccine initiatives.Item Open Access Do health care providers trust product monograph information regarding use of vaccines in pregnancy? A qualitative study(Health Canada, 2018-06-07) Top, Karina; Arkell, C; Graham, Janice; Scott, H; McNeil, Shelly; Mannerfeldt, J; MacDonald, NoniBackground: In uenza immunization is recommended in pregnancy to prevent severe infections in pregnant women and newborns, yet vaccine uptake remains low. Studies suggest that cautionary language in vaccine product monographs regarding safety and use in pregnancy affects health care providers’ perceptions of vaccine safety and how they counsel pregnant women. Objective: To conduct a qualitative analysis of health care provider perceptions of the safety of inactivated in uenza vaccines and their recommendations for use in pregnancy based on product monograph language statements. Methods: Health care providers were recruited at two international health conferences and from teaching programs in Ethiopia, Ghana, Uganda, and Laos during September and October 2015. After reading the product monograph excerpts for three licensed inactivated in uenza vaccines, participants completed a ten-item online survey with quantitative and qualitative components that captured perceptions of vaccine safety. Results: Health care providers identi ed a lack of trust in manufacturers’ and product monograph information. They perceived product monograph language as ambiguous and not “up-to-date” with current evidence. Health care providers wanted product monograph language that clearly conveyed evidence for the risks and bene ts of the vaccine in an understandable manner. Conclusion: This study suggests that adopting best practices in the wording of product monographs would help to support evidence-based use of vaccines in pregnant women.Item Open Access Frailty, fitness and late-life mortality in relation to chronological and biological age(BMC Springer Nature, 2002-02-27) Mitnitski, Arnold; Graham, Janice; Mogilner, Alexander; Rockwood, KennethBackground: People age at remarkably different rates, but how to estimate trajectories of senescence is controversial. Methods: In a secondary analysis of a representative cohort of Canadians aged 65 and over (n = 2914) we estimated a frailty index based on the proportion of 20 deficits observed in a structured clinical examination. The construct validity of the index was examined through its relationship to chronological age (CA). The criterion validity was examined in its ability to predict mortality, and in relation to other predictions about aging. From the frailty index, relative (to CA) fitness and frailty were estimated, as was an individual's biological age. Results: The average value of the frailty index increased with age in a log-linear relationship (r = 0.91; p < 0.001). In a Cox regression analysis, biological age was significantly more highly associated with death than chronological age. The average increase in the frailty index (i.e. the average accumulation of deficits) amongst those with no cognitive impairment was 3 per cent per year. Conclusions: The frailty index is a sensitive predictor of survival. As the index includes items not traditionally related to adverse health outcomes, the finding is compatible with a view of frailty as the failure to integrate the complex responses required to maintain function.Item Open Access The clinical meaningfulness of ADAS-Cog changes in Alzheimer’s disease patients treated with donepezil in an open-label trial(BMC Springer Nature, 2007-08-30) Rockwood, Kenneth; Fay, Sherri; Gorman, Mary; Carver, Daniel; Graham, JaniceBackground: In 6-month anti-dementia drug trials, a 4-point change in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is held to be clinically important. We examined how this change compared with measures of clinical meaningfulness. Methods: This is a secondary analysis of a 12 month open-label study of 100 patients (71 women) diagnosed with mild to moderate AD treated with 5–10 mg of donepezil daily. We studied the observed case, 6-month change from baseline on the ADAS-Cog, the Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus), patient-Goal Attainment Scaling (PGAS) and clinician-GAS (CGAS). Results: At 6 months, donepezil-treated patients (n = 95) were more likely to show no change (+/ - 3 points) on the ADAS-Cog (56%) than to improve (20%) or decline (24%) by 4-points. ADAS- Cog change scores were little correlated with other measures: from -0.09 for PGAS to 0.27 for the CIBIC-Plus. While patients who improved on the ADAS-Cog were less likely to decline on the clinical measures (26%), 43% of patients who declined on the ADAS-Cog improved on at least two of the clinical measures. Conclusion: The ADAS-Cog did not capture all clinically important effects. In general, ADAS-Cog improvement indicates clinical improvement, whereas many people with ADAS-Cog decline do not show clinical decline. The open-label design of this study does not allow us to know whether this is a treatment effect, which requires further investigation.Item Open Access Assessment of factors associated with complete immunization coverage in children ages 12-23 months: A cross sectional study in Nouna district, Burkina Faso(BMC Springer Nature, 2009-10-14) Sanou, Aboubakary; Simboro, Seraphin; Kouyaté, Bocar; Dugas, Marylène; Graham, Janice; Bibeau, GillesBackground: The Expanded Program on Immunization (EPI) is still in need of improvement. In Burkina Faso in 2003, for example, the Nouna health district had an immunization coverage rate of 31.5%, compared to the national rate of 52%. This study identifies specific factors associated with immunization status in Nouna health district in order to advance improved intervention strategies in this district and in those with similar environmental and social contexts. Methods: A cross-sectional study was undertaken in 41 rural communities and one semi-urban area (urban in the text). Data on 476 children aged 12 to 23 months were analyzed from a representative sample of 489, drawn from the Nouna Health Research Centre’s Demographic Surveillance System (DSS) database.The vaccination history of these children was examined.The relationships between their immunization status and social, economic and various contextual variables associated with their parents and households were assessed using Chi square test, Pearson correlation and logistic regression. Results: The total immunization coverage was 50.2% (CI, 45.71; 54.69). Parental knowledge of the preventive value of immunization was positively related to complete immunization status (p = 0.03) in rural areas. Children of parents who reported a perception of communication problems surrounding immunization had a lower immunization coverage rate (p <0.001). No distance related difference exists in terms of complete immunization coverage within villages and between villages outside the site of the health centres. Children of non-educated fathers in rural areas have higher rates of complete immunization coverage than those in the urban area (p = 0.028). Good communication about immunization and the importance of availability of immunization booklets, as well as economic and religious factors appear to positively affect children’s immunization status. Conclusions: Vaccination sites in remote areas are intended to provide a greater opportunity for children to access vaccination services. These efforts, however, are often hampered by the poor economic conditions of households and insufficient communication and knowledge regarding immunization issues. While comprehensive communication may improve understanding about immunization, it is necessary that local interventions also take into account religious specificities and critical economic periods. Particular approaches that take into consideration these distinctions need to be applied in both rural and urban settings.Item Open Access Rendre évident: une approche symétrique de la réglementation des produits thérapeutiques(Érudit, 2010) Graham, Janice; Jones, MavisENGLISH: Within the social studies of science, risk regulation regimes dominated by a technocratic approach are critiqued for neglecting public, socially situated epistemological standpoints, which, it is argued, are more capable of articulating real world concerns and implications of risk. This critique appears to have been tackled through regulatory modernization in several nations, where strategic efforts are being advanced to open up, enable scrutiny and solicit input into decision-making from a broad range of citizens. While we agree that the evidence for risk regulation could benefit from accommodating more ways of knowing (particularly types of knowledge that have a history of being neglected), we argue that it is not only ‘lay’ public knowledges, but also ‘expert’ scientific ones which become neglected in modern risk regulation regimes. In this paper, we draw upon a specific case — modernization in the Canadian health products regulator — to examine the evolving role and nature of evidence. We draw from our own ethnographic research and the relevant literature (risk and regulatory science, boundary work, and symmetrical anthropology) to suggest a symmetrical approach to evidence-based risk regulation. FRENCH: Dans le champ des études sociales de la science, les régimes de régulation du risque appréhendés selon une approche technocratique sont critiqués pour leur attention insuffisante au « public », point de vue épistémologique socialement situé qui pourtant est davantage en mesure d’articuler les préoccupations du monde réel aux implications (collectives) du risque. Il semble qu’on ait répondu à cette critique dans plusieurs pays en modernisant les réglementations et en déployant des efforts stratégiques pour susciter l’ouverture, permettre un examen approfondi et encourager un large éventail de citoyens à s’impliquer dans le processus décisionnel. Tout en reconnaissant que le régime de preuves dans la réglementation du risque aurait grandement avantage à prendre en compte une plus grande diversité de types de savoir (notamment les connaissances qui ont été historiquement négligées), nous soutenons que ce ne sont pas seulement les savoirs publics « profanes », mais aussi les savoirs scientifiques « experts » qui tendent à être négligés dans les régimes modernes de réglementation du risque. Le présent article part d’un cas spécifique — la modernisation de la régulation des produits de santé canadiens — pour rendre compte de l’évolution de la nature et du rôle de l’évidence médicale. En nous appuyant sur une recherche ethnographique et sur la littérature consacrée (science du risque et de la régulation, travaux autour des frontières et anthropologie symétrique), nous proposons une approche symétrique de la réglementation du risque basée sur la production d’un régime de preuves.Item Open Access Global challenges of implementing human papillomavirus vaccines(BMC Springer Nature, 2011) Graham, Janice; Mishra, AmritaHuman Papillomavirus vaccines are widely hailed as a sweeping pharmaceutical innovation for the universal benefit of all women. The implementation of the vaccines, however, is far from universal or equitable. Socio- economically marginalized women in emerging and developing, and many advanced economies alike, suffer a disproportionately large burden of cervical cancer. Despite the marketing of Human Papillomavirus vaccines as the solution to cervical cancer, the market authorization (licensing) of the vaccines has not translated into universal equitable access. Vaccine implementation for vulnerable girls and women faces multiple barriers that include high vaccine costs, inadequate delivery infrastructure, and lack of community engagement to generate awareness about cervical cancer and early screening tools. For Human Papillomavirus vaccines to work as a public health solution, the quality-assured delivery of cheaper vaccines must be integrated with strengthened capacity for community- based health education and screening.Item Open Access Challenges to immunization: the experience of homeless youth(BMC Springer Nature, 2012) Doroshenko, Alexander; Hatchette, Jill; Halperin, Scott; MacDonald, Noni; Graham, JaniceBackground: Homelessness is a critical social issue, both a product of, and contributing to, poor mental and physical health. Over 150,000 young Canadians live on the streets. Homeless youth experience a high incidence of infectious diseases, many of which are vaccine preventable. Early departure from school and limited access to public health services makes them a particularly vulnerable high-risk group. This study explores challenges to obtaining essential vaccines experienced by homeless youth. Methods: A qualitative research study to explore knowledge, attitudes, beliefs, and experiences surrounding immunization of hard-to-reach homeless youth was designed. Participants were recruited for focus groups from Phoenix House and Shelter, a non-profit, community-based organization assisting homeless youth in Halifax, Nova Scotia, Canada. An experienced facilitator guided the recorded discussions. Transcripts of audiotapes were analyzed using a constant comparative method until data revealed a set of exemplars and themes that best captured participants’ knowledge, attitudes, beliefs and experiences surrounding immunization and infectious diseases. Results: Important themes emerged from our analysis. Considerable variability in knowledge about immunization and vaccine preventable diseases was found. The homeless youth in the study had limited awareness of meningitis in contrast to a greater knowledge about sexually transmitted infections and influenza, gained during the H1N1/09 public health campaign. They recognized their poverty as a risk for contracting infectious diseases, along with their inability to always employ known strategies to prevent infectious diseases, due to circumstances. They showed considerable insight into the detrimental effects of poor hygiene, sleeping locations and risk behaviour. Interviewed homeless youth regarded themselves as good compliers of health professional advice and offered valuable suggestions to improve immunization in their population. Conclusions: To provide effective public health interventions, it is necessary to consider the knowledge, attitudes, beliefs, and experiences of hard to reach, high risk groups. Our study shows that homeless youth are interested and capable in discussing immunization. Active targeting of homeless youth for public health immunization programs is needed. Working collaboratively with non-profit organizations that assist homeless youth provides an opportunity to increase their knowledge of infectious risks and to improve immunization strategies in this vulnerable group.Item Open Access Substitute Decision Making About Research: Identifying the Legally Authorized Representative in Four Canadian Provinces(Faculty of Law, McGill University, 2012) Wildeman, Sheila; Bravo, Gina; Dubois, Marie-France; Cohen, Carole; Graham, Janice; Painter, Karen; Bellemare, SuzanneCanada's aging population presents new incentives for research on Alzheimer's and other forms of dementia. But the public interest in advancing knowledge about these diseases must be partnered with a concern for exploitation, in particular where a potential research subject is deemed legally incapable of making a decision about research participation. The Tri-Council Policy Statement requires that the research participation of subjects deemed incapable of consent be contingent upon authorization obtained from their legally authorized representative ("LAR"). However, where the prospective research subject is an adult, the question of who, if anyone, may act as an LAR is often uncertain. While some provinces and territories provide a clear statutory basis for identifying LARs, others do not. We identified four provincial regimes that differ in their legislative approach to LAR identification. Of the four, British Columbia's health care consent legislation explicitly addresses the question of who, if anyone, may act as LAR for the purpose of authorizing an adult's participation in research, even in the absence of an advance directive or guardian. At the time of our study, Alberta's laws only addressed this question clearly where an ad- vance directive was in place. Legislative reforms in that province have since expanded the circumstances in which an LAR for research may be identified. In contrast, both Nova Scotia and Ontario lacked (and continue to lack) any legislation ex- plicitly addressing who, if anyone, may act as LAR for research. Indeed, Ontario's health care consent and substitute decision making laws explicitly state that they do not apply to procedures undertaken for the primary purpose of research. A postal survey of five sub-populations (older adults, informal caregivers, physicians, researchers in aging, and REB members) was conducted in each of the four provinces. Respondents were pre- sented with hypothetical scenarios and asked who, if anyone, had legal authority to make decisions about research participation. The most common re- sponse across provinces, scenarios, and population groups was that a close family member could act as an LAR, regardless of whether provincial laws clearly supported, clearly contradicted, or were un- certain with regard to that result. We conclude that the combined lack of clarity in, and lack of knowledge about, provincial laws relating to LAR identification that our study exposes indicates a fundamental gap in the system of research regula- tion. There is a need for increased legal clarity and public education on this important aspect of research governance.Item Open Access Prepared for the “unexpected”? Lessons from the 2014-16 Ebola epidemic in West Africa on integrating emergent theory designs into outbreak response.(BMJ Publishing Group, 2018-06) Graham, Janice; Lees, Shelley; Le Marcis, Frederic; Faye, Sylvain Landry; Lorway, Robert R.; Ronse, Maya; Abramowitz, Sharon; Peeters Grietens, KoenSummary Box 1. Even seemingly straightforward interventions, such as vaccine delivery, require real-time awareness of emergent on-the-ground local (‘field’) realities. 2. Outbreak response requires thoughtful engagement that include local communities from the start. 3. Methodologies to actively witness, document and integrate unexpected events and consequences of implementations in response are needed. 4. Emergent theory designs hold important disciplinary and methodological implications for implementing and delivering interventions. 5. Emergent theory designs, such as ethnography, are an essential part of effective outbreak response, capturing emerging barriers and facilitators in real time and bridging local and global realities.Item Open Access Technologies of trust in epidemic response: openness, reflexivity and accountability during the 2014-2016 Ebola outbreak in West Africa(BMJ, 2019-02-13) Graham, Janice; Ryan, Molly; Giles-Vernick, TamaraTrust is an essential component of successful cooperative endeavours. The global health response to the 2014–2016 West Africa Ebola outbreak confronted historically tenuous regional relationships of trust. Challenging sociopolitical contexts and initially inappropriate communication strategies impeded trustworthy relationships between communities and responders during the epidemic. Social scientists af liated with the Ebola 100-Institut Pasteur project interviewed approximately 160 local, national and international responders holding a wide variety of roles during the epidemic. Focusing on responder’s experiences of communities’ trust during the epidemic, this qualitative study identi es and explores social techniques for effective emergency response. The response required individuals with diverse knowledges and experiences. Responders’ included on-the-ground social mobilisers, health workers and clinicians, government of cials, ambulance drivers, contact tracers and many more. We find that trust was fostered through open, transparent and reflexive communication that was adaptive and accountable to community-led response efforts and to real-time priorities. We expand on these ndings to identify ‘technologies of trust’ that can be used to promote actively legitimate trustworthy relationships. Responders engaged the social technologies of openness (a willingness and genuine effort to incorporate multiple perspectives), re exivity ( exibly responsive to context and ongoing dialogue) and accountability (taking responsibility for local contexts and consequences) to facilitate relations of trust. Technologies of trust contribute to the development of a framework of practical techniques to improve the acceptance and effectiveness of future emergency response strategies.