Broken supply chains and local manufacturing innovation:Responses to Covid-19 and their implications for policy

The immense scale of the pandemic healthcare supply crisis across Sub-Saharan Africa showed that a stronger industrial base allowed India, and some African countries, to better tackle crucial supply gaps. Governments have been forced by Covid-19 into developing new “socio-technical imaginaries”: shared visions of what is possible and important for local health security. The pandemic confirmed widespread pre-pandemic African predictions that in a major crisis, African countries would find themselves at the back of the queue; that truth is driving a new recognition of industrialisation’s role in building local health security, including the huge challenge of cancer care in Africa.</p

Realistic Ambitions: Technology Transfer for Biologics Platform Technologies

This chapter argues that the recent international support for expanding vaccine production in African countries offers local policymakers and industrialists an opportunity that should be seized, to transition local manufacturing capabilities to produce biologics. Biologics offer a broader portfolio of cancer therapies. Biologics such as monoclonal antibodies represent an incremental innovation for vaccine manufacturers, with lower learning and transition costs than those that would be faced by manufacturers of chemical drugs seeking to move into biologics. However, biologics production in Africa is not only a technological project, it is also political and economic, feeding into geo-politics debates

Manufacturing for Cancer Care in East Africa: Raising the Ambition

This chapter starts with the paradox of unmet need for cancer supplies in Kenya and Tanzania alongside low yet unmet market demand. An apparent lack of ambition is evidenced within the local industrial/innovation system, including manufacturers, entrepreneurs, regulators and policy makers. Pharmaceutical firms were failing to upgrade, expand product ranges and develop new markets, though that was starting to change before 2020. The chapter identifies market disorganisation and fragmentation as a key constraint on generating more sustainable investment and innovation to improve cancer-related manufacturing and finds scope for institutional change to link industrial incentives to health needs

Oncology Drug Production in Sub-Saharan Africa: The Challenge and Opportunity, with Evidence from India

This chapter focuses on the scope for local production in East Africa of essential oncology medication, drawing on evidence of local clinical need; on Indian data on markets for generic oncology medication; and on industrial and regulatory experience. Import-dependence in oncology is almost complete across Sub-Saharan Africa, while India is a key exporter. The chapter documents competition failures in generic oncology markets and demonstrates the huge affordability impact of effective procurement of these medicines within India. Challenges for local oncology manufacturing are identified. The chapter argues that active health-industrial research linkages can build a local African oncology industry

Khat use and psychotic symptoms in a rural Khat growing population in Kenya: a household survey

Background:Khat is an amphetamine like psychostimulant chewed by over 10 million people globally. Khat use is thought to increase the risk of psychosis among its chewers. The evidence around this however remains inconclusive stemming from the scanty number of studies in this area and small study sample sizes. We undertook a large household survey to determine the association between psychotic symptoms and khat chewing in a rural khat growing and chewing population in Kenya. Methods:For this cross-sectional household survey, we randomly selected 831 participants aged 10 years and above residing in the Eastern region of Kenya. We used the psychosis screening questionnaire (PSQ) to collect information on psychotic symptoms and a researcher designed sociodemographic and clinical questionnaire to collect information on its risk factors. We used descriptive analysis to describe the burden of khat chewing and other substance use as well as rates and types of psychotic symptoms. Using a univariate and multivariate analyses with 95% confidence interval, we estimated the association between khat chewing and specific psychotic symptoms. Results:The prevalence of current khat chewing in the region was at 36.8% (n = 306) with a male gender predominance (54.8%). At least one psychotic symptom was reported by 16.8% (n = 168) of the study population. Interestingly, psychotic symptoms in general were significantly prevalent in women (19.5%) compared to men (13.6%) (p = 0.023). Khat chewing was significantly associated with reported strange experiences (p = 0.024) and hallucinations (p = 0.0017), the two predominantly reported psychotic symptoms. In multivariate analysis controlling for age, gender, alcohol use and cigarette smoking, there was a positive association of strange experiences (OR, 2.45; 95%CI, 1.13–5.34) and hallucination (OR, 2.08; 95% C.I, 1.06–4.08) with khat chewing. Of note was the high concurrent polysubstance use among khat chewers specifically alcohol use (78.4%) and cigarette smoking (64.5%). Conclusions:Psychotic symptoms were significantly elevated in khat users in this population. Future prospective studies examining dose effect and age of first use may establish causality

Access to Cancer Care in Kenya: Patients’, Survivors’, Caregivers’ and Health Providers’ Perspectives

Access to health care remains a complex notion with varying interpretations and no universally accepted definition. At least half of the world’s population lacks access to essential health services. The literature identifies “6As” dimensions of Access: Accessibility, Affordability, Availability, Adequacy /Appropriateness, Acceptability and Approachability. This paper employs these dimensions in documenting factors that were found to influence access to cancer care in Kenya. Health and Industry studies were conducted sequentially. The health part of the study reported in this working paper, employed a convergent parallel mixed methods study design which was undertaken in three counties of Meru, Nairobi and Mombasa. A total of 405 patients were interviewed in public sector health facilities, four focus group discussions with cancer survivors and 22 in-depth interviews with caregivers, health workers and policy makers held. Affordability of cancer services was enabled largely by cash payment with incremental use of National Hospital Insurance Fund (NHIF) from entry in health care up to the first treatment, but the high costs of cancer services were a major challenge. Payments for tests, treatment and indirect costs including transport and accommodation potentially impoverished many patients and their families as well as social networks . Facilities were financially supported by County Government funding, business and non-profit partners, and collaborations between health facilities to reduce indirect costs for the patients. Approachability was facilitated by community outreach services, local networks, awareness and knowledge promotion. However, better linkage between the community and health facility was required, especially for screening services. Availability: 30% of survey participants indicated that something they needed at the health facility was unavailable. The missing items included: medication, tests, treatment therapies, pain relief and essential commodities. Qualitative findings identified additional requirements including oncology staff and equipment. Patients also considered aspects of care that were unacceptable, and mentioned fear, stigma, cultural influences, religious and alternative beliefs. Nonetheless, having information and support from family, friends and other patient’s facilitated acceptability of cancer services. Accessibility in terms of distance and time to reach cancer care services located at county or national referral facilities was reported as a challenge for many. Communication, including lack of clarity, mis-diagnosis and non-disclosure of relevant information emerged as an appropriateness concern. It is important to note that the six access dimensions interact and therefore, may not be addressed separately. When these aspects of access to cancer care are facilitated, then access can be improved. Hence, a holistic health system approach to access is desirable, while emphasis should be put on enhancing diagnostic capabilities at lower levels of care in line with the objective of Universal Health Coverage. Mutually supportive interventions to strengthen access can include wider insurance coverage, extended staffing and improved information. When challenges to any of the access dimensions remain, then access to cancer care is undermined

Preliminary report from the World Health Organisation Chest Radiography in Epidemiological Studies project.

Childhood pneumonia is among the leading infectious causes of mortality in children younger than 5 years of age globally. Streptococcus pneumoniae (pneumococcus) is the leading infectious cause of childhood bacterial pneumonia. The diagnosis of childhood pneumonia remains a critical epidemiological task for monitoring vaccine and treatment program effectiveness. The chest radiograph remains the most readily available and common imaging modality to assess childhood pneumonia. In 1997, the World Health Organization Radiology Working Group was established to provide a consensus method for the standardized definition for the interpretation of pediatric frontal chest radiographs, for use in bacterial vaccine efficacy trials in children. The definition was not designed for use in individual patient clinical management because of its emphasis on specificity at the expense of sensitivity. These definitions and endpoint conclusions were published in 2001 and an analysis of observer variation for these conclusions using a reference library of chest radiographs was published in 2005. In response to the technical needs identified through subsequent meetings, the World Health Organization Chest Radiography in Epidemiological Studies (CRES) project was initiated and is designed to be a continuation of the World Health Organization Radiology Working Group. The aims of the World Health Organization CRES project are to clarify the definitions used in the World Health Organization defined standardized interpretation of pediatric chest radiographs in bacterial vaccine impact and pneumonia epidemiological studies, reinforce the focus on reproducible chest radiograph readings, provide training and support with World Health Organization defined standardized interpretation of chest radiographs and develop guidelines and tools for investigators and site staff to assist in obtaining high-quality chest radiographs

Standardized Interpretation of Chest Radiographs in Cases of Pediatric Pneumonia From the PERCH Study.

BACKGROUND.: Chest radiographs (CXRs) are a valuable diagnostic tool in epidemiologic studies of pneumonia. The World Health Organization (WHO) methodology for the interpretation of pediatric CXRs has not been evaluated beyond its intended application as an endpoint measure for bacterial vaccine trials. METHODS.: The Pneumonia Etiology Research for Child Health (PERCH) study enrolled children aged 1-59 months hospitalized with WHO-defined severe and very severe pneumonia from 7 low- and middle-income countries. An interpretation process categorized each CXR into 1 of 5 conclusions: consolidation, other infiltrate, both consolidation and other infiltrate, normal, or uninterpretable. Two members of a 14-person reading panel, who had undertaken training and standardization in CXR interpretation, interpreted each CXR. Two members of an arbitration panel provided additional independent reviews of CXRs with discordant interpretations at the primary reading, blinded to previous reports. Further discordance was resolved with consensus discussion. RESULTS.: A total of 4172 CXRs were obtained from 4232 cases. Observed agreement for detecting consolidation (with or without other infiltrate) between primary readers was 78% (κ = 0.50) and between arbitrators was 84% (κ = 0.61); agreement for primary readers and arbitrators across 5 conclusion categories was 43.5% (κ = 0.25) and 48.5% (κ = 0.32), respectively. Disagreement was most frequent between conclusions of other infiltrate and normal for both the reading panel and the arbitration panel (32% and 30% of discordant CXRs, respectively). CONCLUSIONS.: Agreement was similar to that of previous evaluations using the WHO methodology for detecting consolidation, but poor for other infiltrates despite attempts at a rigorous standardization process

Accuracy of computer-aided chest X-ray in community-based tuberculosis screening: Lessons from the 2016 Kenya National Tuberculosis Prevalence Survey

Community-based screening for tuberculosis (TB) could improve detection but is resource intensive. We set out to evaluate the accuracy of computer-aided TB screening using digital chest X-ray (CXR) to determine if this approach met target product profiles (TPP) for community-based screening. CXR images from participants in the 2016 Kenya National TB Prevalence Survey were evaluated using CAD4TBv6 (Delft Imaging), giving a probabilistic score for pulmonary TB ranging from 0 (low probability) to 99 (high probability). We constructed a Bayesian latent class model to estimate the accuracy of CAD4TBv6 screening compared to bacteriologically-confirmed TB across CAD4TBv6 threshold cut-offs, incorporating data on Clinical Officer CXR interpretation, participant demographics (age, sex, TB symptoms, previous TB history), and sputum results. We compared model-estimated sensitivity and specificity of CAD4TBv6 to optimum and minimum TPPs. Of 63,050 prevalence survey participants, 61,848 (98%) had analysable CXR images, and 8,966 (14.5%) underwent sputum bacteriological testing; 298 had bacteriologically-confirmed pulmonary TB. Median CAD4TBv6 scores for participants with bacteriologically-confirmed TB were significantly higher (72, IQR: 58–82.75) compared to participants with bacteriologically-negative sputum results (49, IQR: 44–57, p<0.0001). CAD4TBv6 met the optimum TPP; with the threshold set to achieve a mean sensitivity of 95% (optimum TPP), specificity was 83.3%, (95% credible interval [CrI]: 83.0%—83.7%, CAD4TBv6 threshold: 55). There was considerable variation in accuracy by participant characteristics, with older individuals and those with previous TB having lowest specificity. CAD4TBv6 met the optimal TPP for TB community screening. To optimise screening accuracy and efficiency of confirmatory sputum testing, we recommend that an adaptive approach to threshold setting is adopted based on participant characteristics