Lunchtime pandemic reading.
Standard disclaimer: this is a roundup of informative pieces I've read that interest me on the severity of the crisis and how to manage it. I am not a qualified medical expert in ANY sense; at best I am reasonably well-read laity. ALWAYS prioritize advice from qualified healthcare experts over some person on Facebook.
This is also available as an email newsletter at https://lunchtimepandemic.substack.com if you prefer the update in your inbox.
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A new therapeutic to help reduce deaths. "This was the first phase 3 study to evaluate baricitinib in addition to the current standard of care, and included patients receiving antivirals, anticoagulants, and corticosteroids. After the earliest publication of the RECOVERY study in June, 2020, the treatment of hospitalised patients with COVID-19 changed with the adoption of dexamethasone as the standard of care. As a result of its design, COV-BARRIER became the first trial to evaluate the benefit and risk of baricitinib when added to the most current standard of care (dexamethasone) in these patients. This was a randomised, double-blind, placebo-controlled trial conducted globally in regions with high COVID-19 hospitalisation rates. The reduction in the composite primary endpoint of progression to non-invasive ventilation, high-flow oxygen, invasive mechanical ventilation, or death for baricitinib plus standard of care (including dexamethasone) compared with placebo plus standard of care was not statistically significant. However, analysis of a prespecified key secondary endpoint showed that treatment with baricitinib reduced 28-day all-cause mortality by 38·2% compared with placebo (HR 0·57 [95% CI 0·41–0·78], nominal p=0·0018), with one additional death prevented per 20 baricitinib-treated participants. The reduction of all-cause mortality with baricitinib was maintained up to day 60 in an exploratory analysis. The frequency of serious adverse events, serious infections, and venous thromboembolic events was similar between the baricitinib and placebo groups.
In this phase 3 trial, baricitinib administered in addition to standard of care (which predominantly included dexamethasone) did not reduce the incidence of a composite endpoint of disease progression, but showed a strong effect on reduction of mortality by 28 days, an effect which was maintained up to 60 days. In the ACTT-2 study, baricitinib further reduced time to recovery above the background use of remdesivir. Taken together, these findings suggest that baricitinib has synergistic effects with other standard-of-care treatment modalities, including remdesivir and dexamethasone. Based on all available evidence, baricitinib is a potentially effective oral treatment option to decrease mortality in hospitalised patients with COVID-19."
Source: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00331-3/fulltext
Commentary: Welcome news for treating the most severe cases of COVID-19.
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A massive mask-trial in Bangladesh. "Background: Mask usage remains low across many parts of the world during the COVID19 pandemic, and strategies to increase mask-wearing remain untested. Our objectives were to identify strategies that can persistently increase mask-wearing and assess the impact of increasing mask-wearing on symptomatic SARS-CoV-2 infections. Methods: We conducted a cluster-randomized trial of community-level mask promotion in rural Bangladesh from November 2020 to April 2021 (N=600 villages, N=342,126 adults). We cross-randomized mask promotion strategies at the village and household level, including cloth vs. surgical masks. All intervention arms received free masks, information on the importance of masking, role modeling by community leaders, and in-person reminders for 8 weeks. The control group did not receive any interventions. Neither participants nor field staff were blinded to intervention assignment. Outcomes included symptomatic SARS-CoV-2 seroprevalence (primary) and prevalence of proper mask-wearing, physical distancing, and symptoms consistent with COVID-19 (secondary). Mask-wearing and physical distancing were assessed through direct observation at least weekly at mosques, markets, the main entrance roads to villages, and tea stalls. At 5 and 9 weeks follow-up, we surveyed all reachable participants about COVID-related symptoms. Blood samples collected at 10-12 weeks of follow-up for symptomatic individuals were analyzed for SARS-CoV-2 IgG antibodies. Results: There were 178,288 individuals in the intervention group and 163,838 individuals in the control group. The intervention increased proper mask-wearing from 13.3% in control villages (N=806,547 observations) to 42.3% in treatment villages (N=797,715 observations) (adjusted percentage point difference = 0.29 [0.27, 0.31]). This tripling of mask usage was sustained during the intervention period and two weeks after. Physical distancing increased from 24.1% in control villages to 29.2% in treatment villages (adjusted percentage point difference = 0.05 [0.04, 0.06]). After 5 months, the impact of the intervention faded, but mask-wearing remained 10 percentage points higher in the intervention group"
Source: https://www.poverty-action.org/sites/default/files/publications/Mask_RCT____Symptomatic_Seropositivity_083121.pdf
Commentary: It's really simple.
Vaccines stop death and serious illness.
Masks stop spread.
You need both.
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FDA regains rulemaking authority. "The Food and Drug Administration once again has the authority to issue its own regulations under a notice issued Tuesday that reverses a Trump-era change.
Former Health and Human Services Secretary Alex Azar issued a memo in September 2020, requiring that all rules coming out of the department’s agencies and offices would need to be signed by the secretary.
The new notice, signed by HHS Secretary Xavier Becerra, “revokes the September 15 Memorandum as it applies to FDA and reinstates any delegations to FDA rescinded by the September 15 Memorandum.”
The move comes as the Biden administration is making a key part of its Covid-19 messaging around putting trust in the science and in the decisions of federal health officials.
The goal of the 2020 move was to minimize “litigation risk for the department’s public health actions” and prevent potential abuse of authority, the HHS said in a statement at the time. Some HHS rules have been challenged in court based on the argument that officials who signed the rules didn’t have the proper rulemaking power.
Rules have to go through a formal clearance process before they can be published. That process includes review by the agency writing the rule, the HHS, press staff, the Office of the General Counsel, and the Office of Management and Budget. Other departments and offices can be involved in the rule if they are relevant to the subject matter.
The process also typically included the signatures of the HHS secretary and the head of the relevant agency, although sometimes other agency officials would sign it, the department said in 2020.
Former FDA Commissioner Scott Gottlieb at the time called the move a “major distraction” that creates “an implication, or at least a specter” that the FDA’s independence is being “eroded or influenced.”"
Source: https://news.bloomberglaw.com/health-law-and-business/fda-regains-rulemaking-authority-in-reversal-of-trump-era-move
Commentary: I would still like to see agencies like the FDA and CDC be made fully independent, similar to agencies like the Federal Reserve Board and FDIC, so that politics has minimal impact on them.
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A reminder of the simple daily habits we should all be taking.
1. Wear the best mask available to you when you'll be around people you don't live with, even after you've been vaccinated. Respirators are back in stock at online retailers, too. Wear an N95/FFP2/KN95 that's NIOSH-approved or better mask if you can obtain it. If you can't get an N95 mask, wear a surgical mask with a cloth mask over it.
2. Verify your mask's NIOSH certification here: https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html
3. Get vaccinated as soon as you're able to, and fulfill the full vaccine regimen. Remember that you are not vaccinated until everyone you live with is vaccinated. If you received an adenovirus vaccine (J&J/AstraZeneca), consider getting an mRNA single shot booster (Pfizer/Moderna) if permitted.
4. Wash/sanitize your hands every time you are in or out of your home.
5. Stay out of indoor spaces that aren't your home and away from people you don't live with as much as practical. Minimize your contact with others and avoid indoor places as much as you can; indoor spaces spread the disease through aerosols and distance is less effective at mitigating your risks.
6. Aim to have 3-6 months of living expenses on hand in case the pandemic gives another crazy plot twist to the economy.
7. Replenish your supplies as you use them. Avoid reducing your stores to pre-pandemic levels in case an outbreak causes unexpected supply chain disruptions.
8. Ventilate your home as frequently as weather and circumstances permit, except when you share close airspaces with other residences (like a window less than a meter away from a neighboring window).
9. Masks must fit properly to work. Here's how to properly fit a mask:
10. If you think you may have been exposed to COVID-19, purchase a rapid antigen test. This will detect COVID-19 only when you're contagious, so follow the directions clearly. https://amzn.to/3fLAoor
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Common misinformation debunked!
There is no basis in fact that COVID-19 vaccines can shed or otherwise harm people around you.
Source: https://www.reuters.com/article/factcheck-covid19vaccine-reproductivepro-idUSL1N2MG256
There is no mercury or other heavy metals in the Pfizer mRNA vaccine.
Source: https://www.technologyreview.com/2020/12/09/1013538/what-are-the-ingredients-of-pfizers-covid-19-vaccine/
There is no basis in fact that COVID-19 vaccines pose additional risks to pregnant women.
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2104983
There is no genomic evidence at all that COVID-19 arrived before 2020 in the United States and therefore no hidden herd immunity:
Source:
There is no evidence SARS-CoV-2 was engineered, nor that it escaped a lab somewhere.
Source: https://www.washingtonpost.com/world/2020/01/29/experts-debunk-fringe-theory-linking-chinas-coronavirus-weapons-research/
Source: https://www.nature.com/articles/s41591-020-0820-9
Source: https://www.nationalgeographic.com/science/2020/05/anthony-fauci-no-scientific-evidence-the-coronavirus-was-made-in-a-chinese-lab-cvd/
Source: https://www.smh.com.au/national/are-we-ignoring-the-hard-truths-about-the-most-likely-cause-of-covid-19-20210601-p57x4r.html
There is no evidence a flu shot increases your COVID-19 risk.
Source: https://www.factcheck.org/2020/04/no-evidence-that-flu-shot-increases-risk-of-covid-19/
Source: https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciaa626/5842161
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Disclosures and Disclaimers
I declare no competing interests on anything I share related to COVID-19. I am employed by and am a co-owner in TrustInsights.ai, an analytics and management consulting firm. I have no clients and no business interests in anything related to COVID-19, nor do I financially benefit in any way from sharing information about COVID-19.
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A common request I'm asked is who I follow. Here's a public Twitter list of many of the sources I read.
https://twitter.com/i/lists/1260956929205112834
This list is biased by design. It is limited to authors who predominantly post in the English language. It is heavily biased towards individual researchers and away from institutions. It is biased towards those who publish or share research, data, papers, etc. I have made an attempt to follow researchers from different countries, and also to make the list reasonably gender-balanced, because multiple, diverse perspectives on research data are essential.
This is also available as an email newsletter at https://lunchtimepandemic.substack.com if you prefer the update in your inbox.