Compassionate drug (mis)use during pandemics: lessons for COVID-19 from 2009.
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ABSTRACT: Background
New emerging infections have no known treatment. Assessing potential drugs for safety and efficacy enables clinicians to make evidence-based treatment decisions and contributes to overall outbreak control. However, it is difficult to launch clinical trials in the unpredictable environment of an outbreak. We conducted a bibliometric systematic review for the 2009 influenza pandemic to determine the speed and quality of evidence generation for treatments. This informs approaches to high-quality evidence generation in this and future pandemics.Methods
We searched PubMed for all clinical data (including clinical trial, observational and case series) describing treatment for patients with influenza A(H1N1)pdm09 and ClinicalTrials.gov for research that aimed to enrol patients with the disease.Results
Thirty-three thousand eight hundred sixty-nine treatment courses for patients hospitalised with A(H1N1)pdm09 were detailed in 160 publications. Most were retrospective observational studies or case series. Five hundred ninety-two patients received treatment (or placebo) as participants in a registered interventional clinical trial with results publicly available. None of these registered trial results was available during the timeframe of the pandemic, and the median date of publication was 213 days after the Public Health Emergency of International Concern ended.Conclusion
Patients were frequently treated for pandemic influenza with drugs not registered for this indication, but rarely under circumstances of high-quality data capture. The result was a reliance on use under compassionate circumstances, resulting in continued uncertainty regarding the potential benefits and harms of anti-viral treatment. Rapid scaling of clinical trials is critical for generating a quality evidence base during pandemics.
SUBMITTER: Rojek AM
PROVIDER: S-EPMC7441224 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:During historical and contemporary crises in the U.S., Blacks and other marginalized groups experience an increased risk for adverse health, social, and economic outcomes. These outcomes are driven by structural factors, such as poverty, racial residential segregation, and racial discrimination. These factors affect communities' exposure to risk and ability to recover from disasters, such as pandemics. This study examines whether areas where descendants of enslaved Africans and other Blacks lived in Chicago were vulnerable to excess death during the 1918 influenza pandemic and whether these disparities persisted in the same areas during the COVID-19 pandemic. To examine disparities, demographic data and influenza and pneumonia deaths were digitized from historic weekly paper maps from the week ending on 5 October 1918 to the week ending on 16 November 1918. Census tracts were labeled predominantly Black or white if the population threshold for the group in a census tract was 40% or higher for only one group. Historic neighborhood boundaries were used to aggregate census tract data. The 1918 spatial distribution of influenza and pneumonia mortality rates and cases in Chicago was then compared to the spatial distribution of COVID-19 mortality rates and cases using publicly available datasets. The results show that during the 1918 pandemic, mortality rates in white, immigrant and Black neighborhoods near industrial areas were highest. Pneumonia mortality rates in both Black and immigrant white neighborhoods near industrial areas were approximately double the rates of neighborhoods with predominantly US-born whites. Pneumonia mortality in Black and immigrant white neighborhoods, far away from industrial areas, was also higher (40% more) than in US-born white neighborhoods. Around 100 years later, COVID-19 mortality was high in areas with high concentrations of Blacks based on zip code analysis, even though the proportion of the Black population with COVID was similar or lower than other racial and immigrant groups. These findings highlight the continued cost of racial disparities in American society in the form of avoidable high rates of Black death during pandemics.
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