Beyond patents: Scientific knowledge, and access to vaccine

Knowledge is a public good. Patents provide property rights in knowledge, which gives the patentee the right to exclude others from utilising the knowledge for the life of the patent. Patents in the field of pharmaceuticals are controversial because of the importance of the knowledge which they exclude others from using. Patents have come under significant criticism for this very reason – with some going as far as to claim that patent protection on pharmaceutical products as the cause of developing states having poor or limited access to life-saving pharmaceutical products. Most of the academic literature regarding access to medicines goes this same way. This paper challenges this viewpoint, and considers the barriers to generic access to medicines beyond patents. This paper looks beyond intellectual property rights to determine what other mechanisms exist that allow innovative vaccine manufacturers to control access to knowledge regarding their products which can act as a barrier to the utilisation of knowledge in the pharmaceutical industry, in a similar manner to intellectual property rights. This paper takes a case study approach considering non-patent-related barriers to access to medicines, focusing on pandemic influenza vaccines and the role of proprietary, non-patented knowledge. This paper concludes that manufacturers have an exclusive monopoly, not because of their intellectual property rights, but because the knowledge required to make the drug is not accessible to generic manufacturers, and highlights why this is the case. This paper argues that it is not the patent protection which is the barrier to introducing generic pandemic influenza vaccines, but rather it is the inaccessibility of knowledge which is not in the public domain, or the inability of manufacturers in developing states to utilise this knowledge, which is the true barrier in this field

Securing circulation pharmaceutically: antiviral stockpiling and pandemic preparedness in the European Union

Governments in Europe and around the world amassed vast pharmaceutical stockpiles in anticipation of a potentially catastrophic influenza pandemic. Yet the comparatively ‘mild’ course of the 2009 H1N1 pandemic provoked considerable public controversy around those stockpiles, leading to questions about their cost–benefit profile and the commercial interests allegedly shaping their creation, as well as around their scientific evidence base. So, how did governments come to view pharmaceutical stockpiling as such an indispensable element of pandemic preparedness planning? What are the underlying security rationalities that rapidly rendered antivirals such a desirable option for government planners? Drawing upon an in-depth reading of Foucault’s notion of a ‘crisis of circulation’, this article argues that the rise of pharmaceutical stockpiling across Europe is integral to a governmental rationality of political rule that continuously seeks to anticipate myriad circulatory threats to the welfare of populations – including to their overall levels of health. Novel antiviral medications such as Tamiflu are such an attractive policy option because they could enable governments to rapidly modulate dangerous levels of (viral) circulation during a pandemic, albeit without disrupting all the other circulatory systems crucial for maintaining population welfare. Antiviral stockpiles, in other words, promise nothing less than a pharmaceutical securing of circulation itself

A survey on knowledge and self-reported formula handling practices of parents and child care workers in Palermo, Italy

Powdered infant formula (PIF) is not a sterile product, but this information appears to be poorly diffused among child caregivers. Parents and child care workers may behave in an unsafe manner when handling PIF. Methods: This study involved parents and child care workers in the 24 municipal child care centres of Palermo. Knowledge and self-reported practices about PIF handling were investigated by a structured questionnaire. A Likert scale was used to measure the strength of the respondent's feelings. Association of knowledge and self-reported practices with demographic variables was also evaluated. Results: 42.4% of parents and 71.0% of child care workers filled in the questionnaire. Significant differences were found between parents and child care workers for age and education. 73.2% of parents and 84.4% of child care workers were confident in sterility of PIF. Generally, adherence to safe procedures when reconstituting and handling PIF was more frequently reported by child care workers who, according to the existing legislation, are regularly subjected to a periodic training on food safety principles and practices. Age and education significantly influenced the answers to the questionnaire of both parents and child care workers. Conclusion: The results of the study reveal that parents and child care workers are generally unaware that powdered formulas may contain viable microorganisms. However, child care workers consistently chose safer options than parents when answering the questions about adherence to hygienic practices. At present it seems unfeasible to produce sterile PIF, but the risk of growth of hazardous organisms in formula at the time of administration should be minimized by promoting safer behaviours among caregivers to infants in both institutional settings and home. \ua9 2009 Calamusa et al; licensee BioMed Central Ltd

Adherence to physical activity recommendations and the influence of socio-demographic correlates – a population-based cross-sectional study

<p>Abstract</p> <p>Background</p> <p>Current physical activity guidelines acknowledge the importance of total health enhancing physical activity (HEPA) compared to leisure time physical activity or exercise alone. Assessing total HEPA may result in different levels of adherence to these as well as the strength and/or direction of associations observed between total HEPA and socio-demographic correlates. The aim of this study was to estimate the proportion of the population adhering to the recommendation of at least 30 minutes of HEPA on most days, and to examine the influences of socio-demographic correlates on reaching this recommendation.</p> <p>Methods</p> <p>Swedish adults aged 18–74 years (n = 1470) were categorized, based on population data obtained using the IPAQ, into low, moderately and highly physically active categories. Independent associations between the physical activity categories and socio-demographic correlates were studied using a multinomial logistic regression.</p> <p>Results</p> <p>Of the subjects, 63% (95% CI: 60.5–65.4) adhered to the HEPA recommendation. Most likely to reach the highly physical active category were those aged < 35 years (OR = 1.8; 95% CI: 1.1–3.3), living in small towns (OR = 1.8; 95% CI: 1.1–2.7) and villages (OR = 2.4; 95% CI: 1.6–3.7), having a BMI between 25.0–29.9 kg/m²(OR = 2.7; 95% CI: 1.4–5.3) having a BMI < 25 kg/m²(OR = 2.5; 95% CI: 1.3–4.9), or having very good (OR = 2.1; 95% CI: 1.3–3.3) or excellent self-perceived health (OR = 4.1; 95% CI: 2.4–6.8). Less likely to reach the high category were women (OR = 0.6; 95% CI: 0.5–0.9) and those with a university degree (OR = 0.5; 95% CI: 0.3–0.9). Similar, but less pronounced associations were observed for the moderate group. Gender-specific patterns were also observed.</p> <p>Conclusion</p> <p>Almost two-thirds of the Swedish adult population adhered to the physical activity recommendation. Due to a large diversity in levels of physical activity among population subgroups, social-ecological approaches to physical activity promotion may be warranted.</p

Medical countermeasures for national security: a new government role in the pharmaceuticalization of society

How do governments contribute to the pharmaceuticalization of society? Whilst the pivotal role of industry is extensively documented, this article shows that governments too are accelerating, intensifying and opening up new trajectories of pharmaceuticalization in society. Governments are becoming more deeply invested in pharmaceuticals because their national security strategies now aspire to defend populations against health-based threats like bioterrorism and pandemics. To counter those threats, governments are acquiring and stockpiling a panoply of ‘medical countermeasures’ such as antivirals, next-generation vaccines, antibiotics and anti-toxins. More than that, governments are actively incentivizing the development of many new medical countermeasures – principally by marshaling the state's unique powers to introduce exceptional measures in the name of protecting national security. At least five extraordinary policy interventions have been introduced by governments with the aim of stimulating the commercial development of novel medical countermeasures: (1) allocating earmarked public funds, (2) granting comprehensive legal protections to pharmaceutical companies against injury compensation claims, (3) introducing bespoke pathways for regulatory approval, (4) instantiating extraordinary emergency use procedures allowing for the use of unapproved medicines, and (5) designing innovative logistical distribution systems for mass drug administration outside of clinical settings. Those combined efforts, the article argues, are spawning a new, government-led and quite exceptional medical countermeasure regime operating beyond the conventional boundaries of pharmaceutical development and regulation. In the first comprehensive analysis of the pharmaceuticalization dynamics at play in national security policy, this article unearths the detailed array of policy interventions through which governments too are becoming more deeply imbricated in the pharmaceuticalization of society

Medical countermeasures for national security: a new government role in the pharmaceuticalization of society

How do governments contribute to the pharmaceuticalization of society? Whilst the pivotal role of industry is extensively documented, this article shows that governments too are accelerating, intensifying and opening up new trajectories of pharmaceuticalization in society. Governments are becoming more deeply invested in pharmaceuticals because their national security strategies now aspire to defend populations against health-based threats like bioterrorism and pandemics. To counter those threats, governments are acquiring and stockpiling a panoply of ‘medical countermeasures’ such as antivirals, next-generation vaccines, antibiotics and anti-toxins. More than that, governments are actively incentivizing the development of many new medical countermeasures – principally by marshaling the state's unique powers to introduce exceptional measures in the name of protecting national security. At least five extraordinary policy interventions have been introduced by governments with the aim of stimulating the commercial development of novel medical countermeasures: (1) allocating earmarked public funds, (2) granting comprehensive legal protections to pharmaceutical companies against injury compensation claims, (3) introducing bespoke pathways for regulatory approval, (4) instantiating extraordinary emergency use procedures allowing for the use of unapproved medicines, and (5) designing innovative logistical distribution systems for mass drug administration outside of clinical settings. Those combined efforts, the article argues, are spawning a new, government-led and quite exceptional medical countermeasure regime operating beyond the conventional boundaries of pharmaceutical development and regulation. In the first comprehensive analysis of the pharmaceuticalization dynamics at play in national security policy, this article unearths the detailed array of policy interventions through which governments too are becoming more deeply imbricated in the pharmaceuticalization of society

Field evaluation of a new antibody-based diagnostic for Schistosoma haematobium and S. mansoni at the point-of-care in northeast Zimbabwe

BACKGROUND: Rapid diagnostic tests (RDTs) for use at the point-of-care (POC) are likely to become increasingly useful as large-scale control programmes for schistosomiasis get underway. Given the low sensitivity of the reference standard egg count methods in detecting light infections, more sensitive tests will be required to monitor efforts aimed at eliminating schistosomiasis as advocated by the World Health Assembly Resolution 65.21 passed in 2012. METHODS: A recently developed RDT incorporating Schistosoma mansoni cercarial transformation fluid (SmCTF) for detection of anti-schistosome antibodies in human blood was here evaluated in children (mean age: 7.65 years; age range: 1-12 years) carrying light S. mansoni and S. haematobium infections in a schistosome-endemic area of Zimbabwe by comparison to standard parasitological techniques (i.e. the Kato-Katz faecal smear and urine filtration). Enzyme-linked immunosorbent assays (ELISAs) incorporating S. haematobium antigen preparations were also employed for additional comparison. RESULTS: The sensitivity of the SmCTF-RDT compared to standard parasitological methods was 100% while the specificity was 39.5%. It was found that the sera from RDT “false-positive” children showed significantly higher antibody titres in IgM-cercarial antigen preparation (CAP) and IgM-soluble egg antigen (SEA) ELISA assays than children identified by parasitology as “true-negatives”. CONCLUSIONS: Although further evaluations are necessary using more accurate reference standard tests, these results indicate that the RDT could be a useful tool for the rapid prevalence-mapping of both S. mansoni and S. haematobium in schistosome-endemic areas. It is affordable, user-friendly and allows for diagnosis of both schistosome species at the POC

Development and preliminary validation of the 'Caring for Country' questionnaire: measurement of an Indigenous Australian health determinant

<p>Abstract</p> <p>Background</p> <p>'Caring for Country' is defined as Indigenous participation in interrelated activities with the objective of promoting ecological and human health. Ecological services on Indigenous-owned lands are belatedly attracting some institutional investment. However, the health outcomes associated with Indigenous participation in 'caring for country' activities have never been investigated. The aims of this study were to pilot and validate a questionnaire measuring caring for country as an Indigenous health determinant and to relate it to an external reference, obesity.</p> <p>Methods</p> <p>Purposively sampled participants were 301 Indigenous adults aged 15 to 54 years, recruited during a cross-sectional program of preventive health checks in a remote Australian community. Questionnaire validation was undertaken with psychometric tests of internal consistency, reliability, exploratory factor analysis and confirmatory one-factor congeneric modelling. Accurate item weightings were derived from the model and used to create a single weighted composite score for caring for country. Multiple linear regression modelling was used to test associations between the caring for country score and body mass index adjusting for socio-demographic factors and health behaviours.</p> <p>Results</p> <p>The questionnaire demonstrated adequate internal consistency, test-retest validity and proxy-respondent validity. Exploratory factor analysis of the 'caring for country' items produced a single factor solution that was confirmed via one-factor congeneric modelling. A significant and substantial association between greater participation in caring for country activities and lower body mass index was demonstrated. Adjusting for socio-demographic factors and health behaviours, an inter-quartile range rise in caring for country scores was associated with 6.1 Kg and 5.3 Kg less body weight for non-pregnant women and men respectively.</p> <p>Conclusion</p> <p>This study indicates preliminary support for the validity of the caring for country concept and a questionnaire designed to measure it. This study also highlights the importance of investigating Indigenous-asserted health promotion activities. Further studies in similar populations are merited to test the generalisability of this questionnaire and to explore associations with other important Indigenous health outcomes.</p

From their own perspective - constraints in the Polio Eradication Initiative: perceptions of health workers and managers in a district of Pakistan's Punjab province

<p>Abstract</p> <p>Background</p> <p>The success of the Global Polio Eradication Initiative was remarkable, but four countries - Afghanistan, Pakistan, India and Nigeria - never interrupted polio transmission. Pakistan reportedly achieved all milestones except interrupting virus transmission. This paper describes the perceptions of health workers and managers regarding constraints in the Polio Eradication Initiative (PEI) to ultimately provide evidence for designing future interventions.</p> <p>Methods</p> <p>A qualitative cross-sectional study using focus group discussions and in-depth interviews was conducted in the Nankana Sahib District of Pakistan's Punjab province. Study subjects included staff at all levels in the PEI at district headquarters, in all 4 tehsils (sub-districts) and at 20 randomly selected primary health centers. In total, 4 FGD and 7 interview sessions were conducted and individual session summary notes were prepared and later synthesized, consolidated and subjected to conceptual analysis.</p> <p>Results</p> <p>The main constraints identified in the study were the poor condition of the cold chain in all aspects, poor skills and a lack of authority in resource allocation and human resource management, limited advocacy and communication resources, a lack of skills and training among staff at all levels in the PEI/EPI in almost all aspects of the program, a deficiency of public health professionals, poor health services structure, administrative issues (including ineffective means of performance evaluation, bureaucratic and political influences, problems in vaccination areas and field programs, no birth records at health facilities, and poor linkage between different preventive programs), unreliable reporting and poor monitoring and supervision systems, limited use of local data for interventions, and unclear roles and responsibilities after decentralization.</p> <p>Conclusion</p> <p>The study highlights various shortcomings and bottlenecks in the PEI, and the barriers identified should be considered in prioritizing future strategies.</p

Telephone Consultation for Improving Health of People Living with or at Risk of HIV: A Systematic Review

BACKGROUND: Low cost, effective interventions are needed to deal with the major global burden of HIV/AIDS. Telephone consultation offers the potential to improve health of people living with HIV/AIDS cost-effectively and to reduce the burden on affected people and health systems. The aim of this systematic review was to assess the effectiveness of telephone consultation for HIV/AIDS care. METHODS: We undertook a comprehensive search of peer-reviewed and grey literature. Two authors independently screened citations, extracted data and assessed the quality of randomized controlled trials which compared telephone interventions with control groups for HIV/AIDS care. Telephone interventions were voice calls with landlines or mobile phones. We present a narrative overview of the results as the obtained trials were highly heterogeneous in design and therefore the data could not be pooled for statistical analysis. RESULTS: The search yielded 3321 citations. Of these, nine studies involving 1162 participants met the inclusion criteria. The telephone was used for giving HIV test results (one trial) and for delivering behavioural interventions aimed at improving mental health (four trials), reducing sexual transmission risk (one trial), improving medication adherence (two trials) and smoking cessation (one trial). Limited effectiveness of the intervention was found in the trial giving HIV test results, in one trial supporting medication adherence and in one trial for smoking cessation by telephone. CONCLUSIONS: We found some evidence of the benefits of interventions delivered by telephone for the health of people living with HIV or at risk of HIV. However, only limited conclusions can be drawn as we only found nine studies for five different interventions and they mainly took place in the United States. Nevertheless, given the high penetration of low-cost mobile phones in countries with high HIV endemicity, more evidence is needed on how telephone consultation can aid in the delivery of HIV prevention, treatment and care