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ngq, you sexy beast! Here is a sanity check for that clean meta. ;)
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                    [post_title] => National Institutes of Health
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                    [post_title] => Gates Foundation & Cytel
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                    [post_title] => Johns Hopkins University
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  • As countries eagerly hope to end the lockdowns that have decimated national economies, one idea that has gained traction is the issuance of immunity passports to those that have either tested negative or recovered from COVID-19. In Nature, however, an article this week outlines four practical challenges and six ethical objections to immunity passports:

      

    1. Unclear whether recovered patients develop immunity to future exposure to virus.
      2. 

    2. Serological testing for antibodies remains unreliable (low specificity and specificity).
      3. 

    3. No country has sufficient serological testing capacity (minimum of two per person).
      4. 

    4. Only a small fraction of the population would be certified (e.g. less than 0.5% of the U.S. population based on current number of confirmed cases).
      5. 

    5. Systems to monitor immunity will erode privacy and increase the risk of forgery.
      6. 

    6. Marginalized communities will be disproportionately impacted, including profiling and potential harms to racial, sexual, religious or other minority groups.
      7. 

    7. Unfair access due to testing shortages and systemic inequities.
      8. 

    8. Create further inequity between immuno-privileged and vulnerable communities.
      9. 

    9. Could open the possibility for discrimination on the basis of other health information (e.g. mental health status, genetic tests) by employers, insurers, or law enforcement.
      10. 

    10. Can lead to perverse incentives, e.g. if social and economic liberties are only granted to people who recover from COVID-19.
      11. 

    

    • 



                    [post_title] => Immunity Passports: 10 practical challenges and ethical objections
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The decision by President Trump to “terminate” relations with the WHO over accusations of undue influence by China on the agency was widely condemned, within the U.S. and globally. It remains uncertain if and how this would happen, but experts worry it may exacerbate global health challenges. The President’s suggestion to redirect intended resources (about US$450 million last year, accounting for 15% of the WHO budget) through bilateral development channels could lead to greater incoherence and inefficiency, according to Rebecca Katz (Georgetown University). A Nature article outlines a range of other possible repercussions, from the resurgence of polio and malaria to barriers in the flow of information on COVID-19. As Dr Kelly Lee (Simon Frasier University) warns, the damage to scientific partnerships would also extend to waning U.S. influence in global health initiatives, including ongoing drug and vaccine development and distribution.


                    [post_title] => What the U.S. 'WHOexit' could mean for Global Health
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The latest media briefing by the WHO warned that the global outlook has been “worsening” over the past week, with over 100,000 daily case reports in nine of the past ten days, as total confirmed cases surpass 7 million and total reported deaths approach half a million. One challenge has been complacency, as the WHO Technical Lead explains “people grow tired” which makes it difficult for governments to maintain or reintroduce public health and social distancing measures. As some regions like parts of Europe are beginning to see stabilizing or declining rates of new COVID-19 infection, Latin America has quickly become the ‘epicentre of the pandemic’. Of the 136,000 reported cases on Monday June 1, 2020, almost 75% came from just 10 countries, more than half of which were from Central and South American countries. The WHO Director General said he was “especially worried” given the large number of countries reporting rapidly increasing case and mortality rates straining health systems “from Mexico through to Chile.”


With almost 600,000 confirmed cases, Brazil has the second highest case count in the world following the U.S. With 2,600 deaths reported in just two days, the WHO Regional Office for the Americas, PAHO, warns that Brazil could see 88,000 deaths from COVID-19 by August unless the country takes drastic containment measures. Elsewhere in the world, Iran has reported more than 3,000 confirmed cases for a fourth consecutive day, raising concerns that the country may be experiencing a second wave of infections.


                    [post_title] => South America emerges as ‘new epicentre of the pandemic’
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The ongoing global protests against police brutality in the United States and the structural racism that enables it, remind us that racism is detrimental, and deadly. As such, racism and structural manifestations are a major public health concern and compound with other issues like COVID-19 to magnify negative impacts on dignity, and on morbidity and mortality.


A recent study by the U.K. Government shows how the risk of death from COVID-19 for ethnic minorities is 10-50% higher risk. The WHO expressed support of the global movement and clarified that attending a mass gathering did not necessarily require more restrictive measures. Instead, WHO officials urged protesters to follow local guidelines in maintaining safe practices, including physical distancing, masks and hand washing.


                    [post_title] => There is no stopping COVID-19 without addressing structural violence and racism
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Chronology of events


On May 1, the NEJM published a study that suggested that two types of blood pressure medications (angiotensin-converting–enzyme inhibitors and angiotensin-receptor blockers) were not associated with worse outcomes in patients with COVID-19, while noting ACE inhibitors in particular had significantly protective effects on mortality.


On May 22, the Lancet published an article by the same authors that found that chloroquine and hydroxychloroquine, explored as potential therapies for COVID-19, did not correspond with improved outcomes and may be associated with higher mortality by up to 30%.


Over the following week, a number of high-profile clinical trials were halted or suspended as a result of the Lancet paper. That included the multi-country Solidarity Trial that was being coordinated by the WHO.


On May 28, more than 180 scientists submitted an open letter to the Lancet editor and study authors outlining questions about the statistical analysis and a lack of transparency in the underlying data, including contributing countries or hospitals.


On June 2, the editors of the NEJM and Lancet issued respective “Expressions of Concern” over methodological and data integrity questions related to the two publications, while the WHO resumed the relevant arm of the Solidarity Trial. Two days later, the co-authors retracted both papers from the NEJM and Lancet, as the journal editors indicated that they would undertake an internal audit of their procedures.


What are the issues?


Data Integrity


Much of the controversy has been around the quality and nature of the large proprietary collection of electronic health records analysed and provided by Surgisphere, a private medical data provider based in the U.S. The primary author of both papers claimed that an independent audit of the data was requested by Medical Technology and Practice Patterns Institute, but were told by the medical data research institute that Surgisphere would not share the underlying data due to “agreements with its clients and the fact that the documents contain confidential information,” It should be noted that Surgisphere Chief Executive was a co-author on the papers. According to a statement on the Surgisphere company website, its data registry was based on electronic health records from customers of its machine learning program and data analytics platform producing data that allows researchers to study “real-world, real-time patient encounters.”


Methodological integrity


The high-profile retractions and pulled pre-print raise broader questions about working with large datasets that researchers are not able to validate, and particularly about how such work could pass peer review at prestigious medical journals.While it is not uncommon for studies to use large datasets without external scrutiny of the raw data, but it is far more uncommon for high-impact journals like the Lancet. While its editor and the NEJM claim the review process was confidential, both journals claim the papers had “external peer review, statistical review, as well as scientific and manuscript editing.” How such a comprehensive dataset could have been gathered from hospitals around the world in the middle of a pandemic is a question that researchers, journals and peer reviewers should have raised.


Adverse Impacts


Although the retrospective analysis was not a randomized control trial, it received a lot of attention given its publication in a high-impact journal and purported scale of almost 100,000 patient records from 671 hospitals around the world between December 2019 and April 2020. Even if the results were correct, however, experts suggest such observational data, with its inherent weaknesses, should not be used to stop trials that could provide definitive and actionable answers. Among the major adverse impacts of the published Lancet study has been suspension of several well-designed clinical trials. One of the major concerns is that the publicity around the Lancet findings have made it harder to conduct trials or recruit patients, as the retraction won’t receive as much attention as the original study. In retrospect, researchers and decision makers may have placed too much reliance on the study, particularly as there had been prior queries about the methods of analysis and some of the results did not fit with what is known about other risk factors. The Annals of Internal Medicine, for example, maintained an ongoing and regularly updated review that summarised data from randomised trials and from observational studies. The journal did not include the Lancet study in their review or conclusion that “at this time, there is insufficient and often conflicting evidence on the benefits and harms of using chloroquine  or hydroxychloroquine to treat COVID-19” that currently make it “impossible to determine the balance of benefits to harms.”


Ensuring research integrity during a pandemic


Scientific publication must above all be rigorous and honest. The retractions raise larger issues of reproducibility and scientific integrity, particularly when using big databases to draw conclusions, an approach that has been gaining rigor in the era of big data. While big databases have opened new lines of inquiry, there are also major issues as experts warn conducting studies properly is far more difficult and require a thorough understanding of underlying data to ensure the methods are rigorous and outcomes reasonable. There have been calls from scientists for independent auditing of data by journals and possibly regulatory bodies like the FDA which has extensive experience of auditing clinical data.


Part of the challenge has been pace. Unlike prior pandemics like SARS and Ebola, the COVID-19 pandemic has led to substantially more scientific publications, most notably pre-prints that are often not peer-reviewed. The rapidly increasing number of publications and urgency to quickly understand the virus present significant challenges in ensuring that research is conducted according to methods and standards of research integrity. This includes, for example, underlying models used to plan pandemic response and predict future outbreak trajectories that are often “poorly reported, at high risk of bias, and reported performance that are optimistic.” Serological tests that have received accelerated approval raise similar concerns, as claims by manufacturers around specificity and sensitivity often lack published data, presenting challenges as countries use testing to determine how to ease lockdowns.


Related papers


    

  • Top journals raise concerns about data in two studies related to COVID-19 (STAT)
    • 

  • High-profile coronavirus retractions raise concerns about data oversight (Nature)
    • 

  • Jeffrey Aronson: When I Use a Word . . . Retraction (BMJ Opinion)
    • 

  • After retractions of two Covid-19 papers, scientists ask what went wrong (STAT)
    • 

  • Will the pandemic permanently alter scientific publishing? (Nature)
    • 



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                    [post_content] => COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University (JH) - Track how the novel coronavirus is spreading around the globe with up-to-date visuals that give context to the data collected on Johns Hopkins University's COVID-19 map.
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Updates on COVID-19 clinical trials


The pace of research and development for treatments and vaccines for the novel Coronavirus has intensified, with dozens of clinical trials underway around the world. Several papers were published over the weekend with preliminary findings on the two largest studies that were both stopped for different reasons.


    

  • In the New England Journal of Medicine, researchers reported on a randomized double-blind study for remdesivir by the U.S. CDC that was stopped prematurely due to positive preliminary results. For patients hospitalised with COVID-19, the antiretroviral appears to reduce the recovery time (by four days) and mortality (from 12% to 7%), while presenting no additional adverse events. While this is promising, the results appear to be worse for visible minorities (a group that has been disproportionately impacted by the pandemic). Researchers have also been surprised that patients treated sooner after symptom onset may not have markedly better outcomes than those treated later in the course of disease.
    • 

  • A paper in the Lancet, meanwhile, presents on the WHO Global COVID-19 Solidarity Trail on chloroquine and hydroxychloroquine. Based on the advice of the WHO Executive Group – comprised of experts from ten countries involved in the trial – the observational study was stopped as preliminary findings suggest the possibility of higher mortality rates. The WHO Chief Scientist committed to a comprehensive analysis of all emerging clinical trial data globally to consider benefit and harm, acknowledging that unlike randomized controlled trials, observational studies have been known to yield misleading results. Expertshave also critiqued the failure of the study to adequately adjust for the fact that many of the patients in the trial are more likely to be severely ill and already at increased risk of death. 
    • 



Ethics of controlled Coronavirus infection


An article in Science this week also expresses concern in the growing trend of researchers pursuing, and thousands of people expressing interest in participating in, controlled human infection (CHI) studies, i.e. deliberately exposing healthy people to COVID-19 to study infection and treatment efficacy. The authors present an ethical framework for CHIs that emphasizes “social value” as fundamental in justifying these studies. The proposed Ethical Framework for SARS-CoV-2 CHI considers six additional criteria, including: Reasonable Risk-Benefit Profile, Context-Specific Stakeholder Engagement, Suitable Site Selection, Fair Participant Selection, Robust Informed Consent, and Proportionate Payment.


Everyone in the (patent) pool


More than 100 former heads of government and leading scientists have urged all COVID-19 related research and intellectual property to be shared freely, and for the equitable distribution of vaccines. An editorial this week in Nature laments that the growing concern of “techno-protectionism” necessitates such a letter, while highlighting the remarkable speed of advancements as a result of global consortia of researchers (“Work that would normally have taken months, possibly years, is completed in weeks”). The Nature article focuses particularly on the patent pool model that is was popularized by the UNITAID Medicines Patent Pool that was successful in bringing antiretrovirals to market.


The World Health Assembly Resolution last week made explicit reference to IP rights flexibilities with respect to R&D, manufacturing and distribution of COVID-19 vaccines. Support was not unanimous, however, as some countries (notably the U.S. and the U.K) and research consortia (including the Coalition for Epidemic Preparedness Innovations) expressed their preference for conventional models where vaccine developers retain the IP rights that they may sub-license and their determined price. An article in the Harvard Business Review drew attention to the dangers of this form of ‘vaccine nationalism’, particularly as the underlying research thus far has been pooled and governments around the world have shouldered much of the risk in funding the vaccine effort.


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A study in Physics of Fluids reporting on the mechanisms of coughing and airborne transmission of viruses. While cough droplets in typical environmental conditions will travel less than the widely mandated 2 meters for social distancing, the authors note that changes in air flow and other environmental properties (e.g. wind, temperature, humidity) can cause that figure to rise quite dramatically. For example, even modest winds (i.e. 4 to 15km/h) could result in saliva droplets dispersing and traveling up to 6 meters. Although the study provides guidelines on the mechanical aspects of droplet transmission, experts suggest the computer simulation may not capture the process of dilution, while the relationship to viral transmission also remains unclear.


A non-peer reviewed pre-print of a study on bioRxiv examining mutations of the novel Coronavirus did not find any variants that had increased transmissibility. While this suggests none of the known mutations are cause for immediate concern, the findings do not rule out the possibility of emerging future variants with different properties. The Director of the Francis Crick Institute has also suggested testing the study conclusions in functional assays of frequently occurring variants in order to examine their proposed mechanisms.


The U.S. Centers for Disease Control and Prevention issued a new guidance with five COVID-19 planning scenarios to public health authorities based on lower and upper bounds across three parameters: virus transmissibility and disease severity, transmission prior to onset of symptoms, and infections that don’t develop symptoms. One of the scenarios, representing the CDC’s “current best estimate about viral transmission and disease severity in the U.S.” (assuming a R0 of 2.5), approximates 35% of COVID-19 infections may be asymptomatic, and that 0.4% of symptomatic positive cases result in mortality. Epidemiologists, however, question the estimates of symptomatic case fatality rate in the scenarios – from 0.2% (least severe) to 1% (most severe) – which is lower than the reported range in the literature.


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The WHO and UNHCR signed an agreement to strengthen partnerships and operational capacities that focus on improving access to health services for some 70 million forcibly displaced people around the world from COVID-19.


The Global Centre for the Responsibility to Protect also issued an appeal to the UN Security Council urging greater protection of civilians in conflict-affected countries. The joint letter, endorsed by dozens of leading global civil society organizations, notes the unprecedented challenges vulnerable and at-risk communities face in a growing number of humanitarian response locations. It also calls on the Security Council to reaffirm and enforce international humanitarian law, calls on practical steps and financial mechanisms, and a whole-of-society and whole-of-UN approach to prevent, respond to and mitigate the impact of COVID-19.


Physicians for Human Rights have also issued a letter that challenges the public health basis for the U.S. CDC’s announcement of indefinite extension of border shutdowns. The letter argues that this policy is driven by immigration politics rather than public health based on an expert review, which warned that this measure needlessly targets and exposes this vulnerable group based on their immigration status, contrary to U.S. law.


Hidden risks of COVID-19: violence against women and girls


UN Women published a report based on a rapid assessment to understand the impact of COVID-19 on violence against women and girls and service provision. The synthesis is based on data collection from government and civil society partners in 49 countries, highlighting the increasing prevalence of gender-based violence that often go unreported. UN Women also released an accompanying pocket tool that provides practical guidelines for gender-responsive evaluation management and data collection, structured around the four main evaluation phases: planning, preparation, conduct, and reporting and follow-up. In a separate article, researchers draw attention to the escalating global crisis in access to reproductive health.


Webinars


Future Strategy Forum: COVID-19 and Grand Strategy (CSIS) | Wednesday, June 3 (1-2pm EST)


Global crises, local action: a humanitarian reset in response to COVID-19 (ODI) | Wednesday, June 3 (6:30pm EST)


Humanitarian Operations During COVID-19: A Conversation with UNHCR (CSIS) | Monday, June 8 (9:30 am EST)


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