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  • Clinical Trials of Monoclonal Antibodies to Prevent COVID-19 Now Enrolling Healthy Adults Who Are At Risk of Infection Due to Close Contact at Work or Home to Persons with SARS-CoV-2 Infection

    illustration of coronavirus

    Two Phase 3, randomized, placebo-controlled, double-blind clinical trials testing whether experimental monoclonal antibodies (mAbs) can prevent infection by SARS-CoV-2 coronavirus are now enrolling healthy adults at clinical trial sites in the United States. Many of the trial sites and study investigators are part of the COVID-19 Prevention Network(link is external) (CoVPN), recently established by the National Institute of Allergy and Infectious Diseases (NIAID), one of the National Institutes of Health. SARS-CoV-2 is the virus that causes coronavirus disease 2019 (COVID-19). The trials are enrolling adults who are at risk of infection due to close contact at work or home to persons with SARS-CoV-2 infection.

    “The COVID-19 Prevention Network is designed to conduct large-scale trials rapidly and efficiently,” said NIAID Director Anthony S. Fauci, M.D. “This network will allow us to test the safety and efficacy of monoclonal antibodies and other preventive measures to help identify how best to reduce the level of SARS-CoV-2 infection and ultimately end the COVID-19 pandemic.”   

    Monoclonal antibodies(link is external) are laboratory-made versions of proteins naturally produced by the immune system in response to invading viruses or other pathogens. Neutralizing antibodies, whether natural or monoclonal, can bind directly to portions of viruses that they use to attach to and enter cells, preventing them from initiating the infection cycle. Monoclonal antibodies may provide short-term protection from SARS-CoV-2 and could serve as important components of the COVID-19 pandemic response until vaccines become available.

    One trial is being conducted jointly by NIAID and trial sponsor Regeneron Pharmaceuticals of Tarrytown, New York. It will evaluate Regeneron’s investigational double mAb combination, REGN-COV-2, which is designed to bind to two points on the SARS-CoV-2 spike protein and prevent it from entering healthy cells. The trial will enroll approximately 2,000 asymptomatic adults who are household contacts of persons with SARS-CoV-2 infection. Participants must have been in close contact (typically due to residing at the same address) with the infected person in a 96-hour window preceding administration of either REGN-CoV-2 or placebo. In addition to assessing safety, the trial will seek to define whether REGN-COV-2 can prevent infection or disease symptoms in those already infected. The efficacy assessment will be a one-month period following administration of REGN-COV-2 or placebo. All trial participants will be followed for safety for seven months after efficacy assessment period ends.

    Additional details about this trial are available at clinicaltrials.gov using the identifier NCT04452318. Interested participants can also visit the CoVPN website(link is external) for details. Doctors or potential participants may also contact the sponsor’s Clinical Trials Administrator at 844-734-6643 or clinicaltrials@regneneron.com(link sends e-mail) for information on enrolling. 

    A second trial, sponsored by Eli Lilly and Company of Indianapolis, Indiana, and implemented in collaboration with NIAID, will evaluate LY-CoV555, a mAb isolated from a recovered COVID-19 patient by scientists at AbCellera (Vancouver, British Columbia, Canada) and the NIAID Vaccine Research Center, and developed by Eli Lilly and Company. This trial will assess whether LY-CoV555 can prevent SARS-CoV-2 infection among people at high risk of exposure due to residing or working in skilled nursing or assisted living facilities. Within one week of identification of a case of SARS-CoV-2 infection at a facility, study investigators will enroll trial volunteers and evaluate the prevention efficacy and safety of LY-CoV555, compared to placebo, over an 8-week period. The trial will also evaluate efficacy in preventing symptoms of a given severity in those already infected. Participants will continue to be followed for safety for an additional 16 weeks. Up to 2,400 participants will be randomized to receive intravenous infusion of either LY-CoV555 or placebo.

    Additional information about this trial is available at clinicaltrials.gov using the identifier NCT04497987. Clinical investigators, hospitals or clinical sites interested in participating in one of Lilly’s clinical trials for a potential COVID-19 treatment, should call 1-877-CT-LILLY (1-877-285-4559) or email covid19potentialsite@lilly.com(link sends e-mail).

    NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

    About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

    NIH…Turning Discovery Into Health®

    Note

    People 18 years of age and older who are interested in participating in these trials should visit the COVID-19 Prevention Network(link is external). Please do not contact the NIAID Media phone number or email to inquire about enrolling in the trials.

  • The Autobiography of a Garden at The Huntington, a Joy for Viewers and Gardeners

    And Do Not Forget the Huntingdon Store: https://www.thehuntingtonstore.org/ nor the walk through the Huntingdon Gardens at night, a reminder from a good and loving friend.

    Andrew Raftery, January: Reading Seed Catalogs, 2009-16, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.
    Andrew Raftery, January: Reading Seed Catalogs, 2009–16, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.  The Huntington is located in San Marino, CA
     

    When the COVID-19 health crisis that has upended all our lives is over and The Huntington is again fully open to the public, one life-affirming pleasure awaiting visitors will be found in The Huntington Art Gallery’s Works on Paper Room. There, displayed against walls of saturated blue, is a resonant, even elegiac, visual narrative. The story that it tells of life and renewal is not on paper, but on 12 uniquely bordered, luminous, ceramic plates revealing in keenly observed detail “The Autobiography of a Garden,” a month-to-month evolution of a real-life garden in Providence, Rhode Island.

    The exhibition, on view through July 5, 2021,  is the work of American painter and printmaker Andrew Raftery and is the product of his inventive, modern-day approach to the transfer of print images onto ceramic, a process dating back to the mid-18th century.

    Raftery, a professor of printmaking at the Rhode Island School of Design, specializes in engraved scenes of contemporary American suburbia. His portfolios, Suit Shopping (2002) and Open House (2008), were collected by the Whitney Museum of American Art, Metropolitan Museum of Art, Cleveland Museum of Art, the Boston Museum of Fine Arts, and the British Museum. He is a 2008 fellow of the John Simon Guggenheim Memorial Foundation, as well as a member of the National Academy of Design.

    Andrew Raftery, February: Planting Seeds, 2009-16, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.
    Andrew Raftery, February: Planting Seeds, 2009–16, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.
     

    Eight years in the making, “The Autobiography of a Garden” marks the realization of Raftery’s long-held desire to transfer his engravings to a potentially functional ceramic object, rather than paper. His visual story at The Huntington, told in fine-lined detail and concurrent with the garden he designed and planted at his mother’s home, begins in January, on a plate entitled “Reading Seed Catalogs.” It depicts Raftery himself, perusing a seed catalog while lying in bed. The walls of his room are hung with framed prints by old masters; jeans and a pair of long johns are thrown over an armchair. Other seed catalogs lie discarded on a rumpled throw rug beside the bed.

    In February, Raftery has portrayed himself in robe and slippers, sitting at his kitchen table, planting seeds in a container. A display of ceramic transfer ware plates, representative of Raftery’s own large collection of antique dishes—some nearly 200 years old—covers the walls; more of these antiques sit in the kitchen sink.

    Transfer ware, once wildly popular, fell out of fashion some time ago. Raftery sought to reclaim it, working through a painstaking process involving ceramics, engraving, printing, and several experts in each area, to bring his work to life. “The plates in our collection are very much a part of our lives whether they’re on the walls or on the table,” maintains Raftery. He feels a kinship, he says, to the workers and designers who made them and views them as a microcosm “of the way people lived, how they imagined the world, their desire for decoration in their lives.”

    Andrew Raftery, March: Watering the Cold Frame, 2009-16, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.
    Andrew Raftery, March: Watering the Cold Frame, 2009–16, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.
     

    The year in the garden progresses from plate to plate. Scenes change according to the months they represent: bushes and flowers grow and blossom; plants are trimmed, weeded, and watered, and die away; bulbs are gathered, and, finally, in December, there are a barren winter landscape and Raftery’s footsteps in the snow. (Drawing and painting a garden as it grew presented a unique challenge: “If one year I didn’t get to draw the tulips in April,” Raftery states, “I had to wait until the next April to do it.”)

    Stamped on the back of each plate, a cartouche with ornamentation related to the design on the front displays such plainly descriptive titles as “Cultivating the Lettuce,” “Watering the Cold Frame,” “Bringing in the Chrysanthemums.” The unique edges of the plates, too, have meaning. The clockwise, saw-toothed edge for March, for instance, represents time “springing forward.”

    The “understory” of the plates, Raftery explains, encompasses the time that he spent with his mother (who just turned 90) during the project, “and how special the garden was as an experience at her house and how it relates to her work as an artist.” Raftery’s mother, a painter, employs the flowers in her garden as subjects in her expressionist works. “And it definitely has to do with the passage of time; it definitely deals with mortality,” Raftery adds. “But then it has the positive side that makes gardening so wonderful: there’s always next season.”

    Andrew Raftery, April: Edging the Beds, 2009-2016, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.
    Andrew Raftery, April: Edging the Beds, 2009–16, engravings transfer printed on glazed white earthenware, diameter: 12 1/2 in. (31.8 cm). The Huntington Library, Art Museum, and Botanical Gardens. Purchased with funds from Richard Benefield and John F. Kunowski. © Andrew Raftery.

  • National Institutes of Health Launches Clinic Trial To Test Antibody Treatment in Hospitalized Covid-19 Patients


    Arial of NIH natinon testing

    Study aims to determine safety and efficacy of experimental monoclonal antibodies. NIH Clinical Research Center

    Patients admitted with COVID-19 at select hospitals may now volunteer to enroll in a clinical trial to test the safety and efficacy of a potential new treatment for the disease. The Phase 3 randomized, controlled trial is known as ACTIV-3, and as a “master protocol,” it is designed to expand to test multiple different kinds of monoclonal antibody treatments. It also can enroll additional volunteers in the middle of the trial, if a specific investigational treatment shows promise.

    The new study is one of four ongoing or planned trials in the National Institutes of Health’s. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, a public-private partnership to speed development of the most promising treatments and vaccine candidates. It also is receiving support through Operation Warp Speed(link is external), the U.S. government’s multi-agency effort to develop, manufacture and distribute medical countermeasures to fight COVID-19.

    The trial will take place at select hospitals around the world that are part of existing clinical trial networks. They include the lead network, the International Network of Strategic Initiatives in Global HIV Trials (INSIGHT), operated by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health. Collaborating clinical trial networks include the Prevention and Early Treatment of Acute Lung Injury network (PETAL) and Cardiothoracic Surgical Trials Network (CTSN), supported by the NIH’s National Heart, Lung and Blood Institute through the Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) program, and the U.S. Department of Veterans Affairs Medical Centers.

    “Under Operation Warp Speed, the U.S. Government has brought together multiple agencies to accelerate the development, manufacture and distribution of medical countermeasures for COVID-19,” said NIH Director Dr. Francis S. Collins, M.D., Ph.D. “The ACTIV studies are just a few examples of this critical activity, which emphasizes flexibility and minimizes delays to generate scientifically sound results.”

    ACTIV-3 uses an adaptive two-stage Phase 3 protocol design. The ACTIV-3 trial can be modified to test additional experimental therapeutics and flexibly allow novel therapeutics to enter at either stage 1 or stage 2. In addition, if a treatment appears to be safe and effective in the initial stage after review by an independent data and safety monitoring board (DSMB), the investigational therapeutic proceeds to stage 2 testing, where more volunteers are enrolled. If an investigational therapeutic is unsafe or not likely to be effective, it will be dropped.

    The ACTIV-3 study will begin by studying the investigational monoclonal antibody LY-CoV555, which was identified in a blood sample from a recovered COVID-19 patient. Antibodies are infection-fighting proteins made by the immune system that can bind to the surface of viruses and prevent them from infecting cells. Synthetic versions of antibodies can be reproduced in a laboratory. These manufactured antibodies are known as monoclonal antibodies. The LY-CoV555 antibody was discovered by Abcellera Biologics (Vancouver, British Columbia) in collaboration with NIAID’s Vaccine Research Center. Subsequently, it was developed and manufactured by Lilly Research Laboratories, Eli Lilly and Company (Indianapolis, Indiana), in partnership with AbCellera. The investigational product also is being tested in another ongoing NIAID study, ACTIV-2, which is studying its safety and efficacy in people with mild to moderate symptoms of COVID-19 who have not been hospitalized. Safety data and other findings will be shared across the ACTIV-2 and ACTIV-3 studies through the DSMB.

    “Studying the impact of this investigational therapeutic on multiple patient populations at the same time is critical to determining whether it can help COVID-19 patients with differing levels of disease severity,” said NIAID Director Anthony S. Fauci, M.D. “These concurrent trials have the potential to yield significant and comprehensive clinical data.”

    The initial stage of the ACTIV-3 clinical trial aims to enroll approximately 300 volunteers who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms. Once their COVID-19 infections have been confirmed and they have consented to take part in the study, participants will be randomly assigned to receive either an intravenous (IV) infusion of LY-CoV555 or a saline placebo infusion. Participants also will receive standard care for COVID-19, including the antiviral remdesivir. After five days, participants’ symptoms will be assessed, as will their need for supplemental oxygen, mechanical ventilation, or other supportive care. Volunteers will be followed for 90 days after enrollment and will receive regular examinations and have blood samples taken periodically during this time to analyze their response to the investivational therapeutic.

    Data collected on the fifth day of the volunteers’ participation will determine whether the investigational therapeutic will be administered to a larger group of volunteers. If LY-CoV555 appears to be safe and appears to be effective, the trial will enroll an additional 700 participants. It also will begin enrolling more severely ill participants, such as those with organ failure requiring mechanical support, or COVID-19-associated dysfunction of organs other than the lungs. The primary endpoint of the trial is the participants’ sustained recovery for 14 days after release from the hospital.

    The principal investigator of ACTIV-3 is Jens Lundgren, M.D., of the University of Copenhagen and Rigshospitalet. Leads of the participating networks include James Neaton, Ph.D., of the INSIGHT network, Taylor Thompson, M.D., of the PETAL network, Annetine Gelijns, Ph.D., and Alan Moskowitz, M.D., of the CTSN, and Rachel Ramoni, D.M.D., Sc.D., of the U.S. Department of Veterans Affairs. To ensure that the trial is being conducted in a safe and effective manner, an independent DSMB will oversee the trial and conduct periodic reviews of the accumulating data.

    NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.

    About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

  • Women’s Congressional Weekly Legislative Update: Paycheck Protection Program Restrictions, Child Care Grants, Pandemic Unemployment Assistance

    Bills Introduced:  July 27-31Katie Porter

    H.R. 7792 — Rep. Roger Marshall (R-KS)/Small Business (7/27/20) — A bill to prohibit abortion providers from receiving a covered loan under the Paycheck Protection Program, and for other purposes.

    H.R. 7802 — Rep. Debbie Lesko (R-AZ)/Small Business (7/27/20) — A bill to require the Planned Parenthood Federation of America and any affiliates to return amounts received under the Paycheck Protection Program, and for other purposes.

    Rep. Katie Porter, right,  D-CA

    Child Care

    H.R. 7804 — Rep. Tom Reed (R-NY)/Education and Labor (7/27/20) — A bill to provide for grants to support the provision of child care by reopening and maintaining the operation of child care programs.

    H.R. 7846 — Rep. Katie Porter (D-CA)/Ways and Means (7/29/20) — A bill to ensure access to Pandemic Unemployment Assistance for workers who are unable to obtain child and family care, and for other purposes.

    S. 4383 — Sen. Joni Ernst (R-IA)/Environment and Public Works (7/30/20) — A bill to make projects that directly or indirectly increase the accessibility of affordable, quality child care eligible for certain grants, and for other purposes.

    H.R. 7909 — Rep. Abby Finkenauer (D-IA)/Education and Labor (7/31/20) — A bill to facilitate access to child care services safely and securely during the COVID-19 pandemic.

    Child Protection

    H.R. 7919 — Rep. Abigail Spanberger (D-VA)/Judiciary (7/31/20) — A bill to direct the attorney general to convene a national working group to study proactive strategies and needed resources for the rescue of children from sexual exploitation and abuse, and for other purposes.

    Employment

    S. 4374 — Sen. Bob Menendez (D-NJ)/Homeland Security and Governmental Affairs (7/30/20) — A bill to establish a government-wide initiative to promote diversity and inclusion in the federal workforce, and for other purposes.

    Family Support

    H.R. 7794 — Rep. Marcia Fudge (D-OH)/Agriculture (7/27/20) — A bill to extend existing Supplemental Nutrition Assistance Program (SNAP) flexibilities for states during the COVID-19 pandemic.

    H.R. 7899 — Rep. Matt Cartwright (D-PA)/Agriculture (7/31/20) — A bill to provide an incentive for households participating in the Supplemental Nutrition Assistance Program (SNAP) to purchase certain nutritious fruits and vegetables that are beneficial to good health.

    H.R. 7916 — Rep. Gwen Moore (D-WI)/Ways and Means; Agriculture (7/31/20) — A bill to temporarily waive section 115 of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 as applied to the Temporary Assistance for Needy Families (TANF) and SNAP programs, and for other purposes.

    Miscellaneous

    H.R. 7881 — Rep. Ted Lieu (D-CA)/Judiciary; Education and Labor (7/30/20) — A bill to provide congressional oversight of the board of directors of the United States Olympic and Paralympic Committee and to protect amateur athletes from emotion, physical, and sexual abuse, and for other purposes.

    Tax Policy

    H.R. 7861 — Rep. John Carter (R-TX)/Ways and Means (7/30/20) — A bill to make permanent the employer credit for paid family and medical leave.

    Editor’s Note:  Text courtesy of Women’s Congressional Policy Institute

     

  • The “Mother” of All Pandemics: Almost All Cases of Influenza A Worldwide Have Been Caused by Descendants of the 1918 Virus

    “Curiouser and curiouser!” cried Alice

    Lewis Carroll, Alice’s Adventures in Wonderland, 1865, 

    The Project Gutenberg EBook of Tenniel Illustrations for Alice in
Wonderland, by Sir John Tenniel

                                        Alice in Wonderland

    An estimated one third of the world’s population (or ≈500 million persons) were infected and had clinically apparent illnesses (1,2) during the 1918–1919 influenza pandemic. The disease was exceptionally severe. Case-fatality rates were >2.5%, compared to <0.1% in other influenza pandemics (3,4). Total deaths were estimated at ≈50 million (5–7) and were arguably as high as 100 million (7).

    The impact of this pandemic was not limited to 1918–1919. All influenza A pandemics since that time, and indeed almost all cases of influenza A worldwide (excepting human infections from avian viruses such as H5N1 and H7N7), have been caused by descendants of the 1918 virus, including “drifted” H1N1 viruses and reassorted H2N2 and H3N2 viruses. The latter are composed of key genes from the 1918 virus, updated by subsequently incorporated avian influenza genes that code for novel surface proteins, making the 1918 virus indeed the “mother” of all pandemics.

    In 1918, the cause of human influenza and its links to avian and swine influenza were unknown. Despite clinical and epidemiologic similarities to influenza pandemics of 1889, 1847, and even earlier, many questioned whether such an explosively fatal disease could be influenza at all. That question did not begin to be resolved until the 1930s, when closely related influenza viruses (now known to be H1N1 viruses) were isolated, first from pigs and shortly thereafter from humans. Seroepidemiologic studies soon linked both of these viruses to the 1918 pandemic (8). Subsequent research indicates that descendants of the 1918 virus still persists enzootically in pigs. They probably also circulated continuously in humans, undergoing gradual antigenic drift and causing annual epidemics, until the 1950s. With the appearance of a new H2N2 pandemic strain in 1957 (“Asian flu”), the direct H1N1 viral descendants of the 1918 pandemic strain disappeared from human circulation entirely, although the related lineage persisted enzootically in pigs. But in 1977, human H1N1 viruses suddenly “reemerged” from a laboratory freezer (9). They continue to circulate endemically and epidemically.

    Thus in 2006, 2 major descendant lineages of the 1918 H1N1 virus, as well as 2 additional reassortant lineages, persist naturally: a human epidemic/endemic H1N1 lineage, a porcine enzootic H1N1 lineage (so-called classic swine flu), and the reassorted human H3N2 virus lineage, which like the human H1N1 virus, has led to a porcine H3N2 lineage. None of these viral descendants, however, approaches the pathogenicity of the 1918 parent virus. Apparently, the porcine H1N1 and H3N2 lineages uncommonly infect humans, and the human H1N1 and H3N2 lineages have both been associated with substantially lower rates of illness and death than the virus of 1918. In fact, current H1N1 death rates are even lower than those for H3N2 lineage strains (prevalent from 1968 until the present). H1N1 viruses descended from the 1918 strain, as well as H3N2 viruses, have now been cocirculating worldwide for 29 years and show little evidence of imminent extinction. to:

    Trying To Understand What Happened

    By the early 1990s, 75 years of research had failed to answer a most basic question about the 1918 pandemic: why was it so fatal? No virus from 1918 had been isolated, but all of its apparent descendants caused substantially milder human disease. Moreover, examination of mortality data from the 1920s suggests that within a few years after 1918, influenza epidemics had settled into a pattern of annual epidemicity associated with strain drifting and substantially lowered death rates. Did some critical viral genetic event produce a 1918 virus of remarkable pathogenicity and then other critical genetic event occur soon after the 1918 pandemic to produce an attenuated H1N1 virus?

    In 1995, a scientific team identified archival influenza autopsy materials collected in the autumn of 1918 and began the slow process of sequencing small viral RNA fragments to determine the genomic structure of the causative influenza virus (10). These efforts have now determined the complete genomic sequence of 1 virus and partial sequences from 4 others. The primary data from the above studies (11–17) and a number of reviews covering different aspects of the 1918 pandemic have recently been published (18–20) and confirm that the 1918 virus is the likely ancestor of all 4 of the human and swine H1N1 and H3N2 lineages, as well as the “extinct” H2N2 lineage. No known mutations correlated with high pathogenicity in other human or animal influenza viruses have been found in the 1918 genome, but ongoing studies to map virulence factors are yielding interesting results. The 1918 sequence data, however, leave unanswered questions about the origin of the virus (19) and about the epidemiology of the pandemic.

    Go to:

  • The GDP: Gross Domestic Product, 2nd Quarter 2020 (Advance Estimate) and Annual Update

    From the St. Louis Federal Reserve’s Fed Reserve image

    Explanation of GDP: GDP as a Measure of Economic Well-Being; St. Louis Federal Reserve Building

    GDP serves as a gauge of our economy’s overall size and health. GDP measures the total market value (gross) of all U.S. (domestic) goods and services produced (product) in a given year.

    When compared with prior periods, GDP tells us whether the economy is expanding by producing more goods and services, or contracting due to less output. It also tells us how the U.S. is performing relative to other economies around the world.

    Economic growth rates are monitored closely, which is why GDP is often reported as a percentage. Reported rates are typically based on “real GDP,” which is adjusted to eliminate the effects of inflation.

    Gross Domestic Product, 2nd Quarter 2020 (Advance Estimate) and Annual Update Real gross domestic product (GDP) decreased at an annual rate of 32.9 percent in the second quarter of 2020 (table 1), according to the “advance” estimate released by the Bureau of Economic Analysis. In the first quarter, real GDP decreased 5.0 percent. Editor’s Note: The BEA, Bureau of Economic Analysis released this data. The GDP estimate released today is based on source data that are incomplete or subject to further revision by the source agency (see “Source Data for the Advance Estimate” on page 2). The “second” estimate for the second quarter, based on more complete data, will be released on August 27, 2020.

    Real gross domestic product (GDP) decreased at an annual rate of 32.9 percent in the second quarter of 2020 (table 1), according to the “advance” estimate released by the Bureau of Economic Analysis. In the first quarter, real GDP decreased 5.0 percent.

    The GDP estimate released today is based on source data that are incomplete or subject to further revision by the source agency (see “Source Data for the Advance Estimate” on page 2). The “second” estimate for the second quarter, based on more complete data, will be released on August 27, 2020.

    Chart showing Real GDP: Percent change from preceding quarter
    Coronavirus (COVID-19) Impact on the Second-Quarter 2020 GDP Estimate
    The decline in second quarter GDP reflected the response to COVID-19, as “stay-at-home” orders issued in March and April were partially lifted in some areas of the country in May and June, and government pandemic assistance payments were distributed to households and businesses. This led to rapid shifts in activity, as businesses and schools continued remote work and consumers and businesses canceled, restricted, or redirected their spending. The full economic effects of the COVID-19 pandemic cannot be quantified in the GDP estimate for the second quarter of 2020 because the impacts are generally embedded in source data and cannot be separately identified. For more information, see the Technical Note.

    The decrease in real GDP reflected decreases in personal consumption expenditures (PCE), exports, private inventory investment, nonresidential fixed investment, residential fixed investment, and state and local government spending that were partly offset by an increase in federal government spending. Imports, which are a subtraction in the calculation of GDP, decreased (table 2).

    The decrease in PCE reflected decreases in services (led by health care) and goods (led by clothing and footwear). The decrease in exports primarily reflected a decrease in goods (led by capital goods). The decrease in private inventory investment primarily reflected a decrease in retail (led by motor vehicle dealers). The decrease in nonresidential fixed investment primarily reflected a decrease in equipment (led by transportation equipment), while the decrease in residential investment primarily reflected a decrease in new single-family housing.

  • OVER-THE-COUNTER DRUGS: GAO’s Information on FDA’s Regulation of Most OTC Drugs

    For years, most over-the-counter drugs followed requirements called “monographs” for each category of drugs (e.g., sunscreen or cough and cold medicine). To update a monograph, FDA followed the federal rulemaking process, which could take years.

    In March 2020, the CARES Act gave FDA new tools to regulate these over-the-counter drugs, such as a new process for updating and finalizing requirements, authority for FDA to collect user fees to support its activities, an expedited process for addressing serious safety issues

    drug store aisle

    GAO-20-572: Published: Jul 29, 2020. Publicly Released: Jul 29, 2020

     Why GAO Did This Study

    OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA’s ability to quickly update and finalize monographs in response to potential safety issues for consumers.

    Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA’s regulation of OTC drugs.

    This report describes, among other issues, (1) the factors that affected FDA’s ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs.

    GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers.

    The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate.

     

    What GAO Found

    The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs — that is, drugs available without a prescription — through the OTC monograph process. FDA has described an OTC monograph as a “rulebook” for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions — such as active ingredients, indications for use, dosage forms, and product labeling — under which an OTC drug was generally recognized as safe and effective.

    According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency’s ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency’s analysis of the effect of the CARES Act is still ongoing.

    FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency’s adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug’s labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed.

    According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA’s ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug’s labeling to mitigate a significant or unreasonable risk of a serious adverse event.

  • Some of Representative John Lewis’ Most Recent Statements: “The Conscience of Congress”; Former President Barack Obama on Lewis’ Death

    Civil Rights and Liberties

    “Over the last several decades, Congress has addressed some of our most pressing civil rights concerns by passing bipartisan legislation that protects American workers from discrimination on the basis of color, race, religion, age, disability and sex.  Our civil rights laws have strengthened our country, and brought us closer to the Beloved Community where all people are able to succeed based on their abilities, not on the labels used to limit them. john lewis and barack obama

     

     

     

     

     

     

     

     

     

     

    President Barack Obama hugs Rep. John Lewis, D-Ga., after his introduction during the event to commemorate the 50th Anniversary of Bloody Sunday and the Selma to Montgomery civil rights marches, at the Edmund Pettus Bridge in Selma, Ala., March 7, 2015. (Official White House Photo by Pete Souza)

    “We have taken some stumbles backward in recent years.  The Supreme Court has weakened some of these basic protections in ways that Congress never intended.  They have undermined the protections for workers, for older Americans, for the disabled, for racial and ethnic minorities, for women and for those in the military.  We must work together to restore those rights. 

    But we have also taken some wonderful steps forward recently with the passage of the Lilly Ledbetter Fair Pay Act, the Matthew Shepard Local Law Enforcement Hate Crimes Prevention Act, repealing the military’s Don’t Ask, Don’t Tell Policy, all of which I was happy to vote for.

    The struggle for civil rights and human rights is bigger than one law, one vote, or one judicial decision.  It’s beyond one presidential term or act of Congress.  Ours is the struggle of a lifetime, and each generation, each citizen, each president and each member of Congress must do his or her part.  It has always required ordinary men and women with extraordinary vision, who have helped build this democracy.  Together all of our efforts comprise the struggle of a nation to build the Beloved Community, a nation at peace with itself, that respects the worth and dignity of each and every human being. 

    Rep. Lewis Supports the George Floyd Justice in Policing Act

    WASHINGTON – Rep. John Lewis (D-GA) submitted the following Floor Statement in support of H.R. 7120, the George Floyd Justice in Policing Act, that passed the U.S. House of Representatives by a vote of 236 to 181 on June 25.

    Mr. Lewis:  “Madam Speaker, I rise in strong support of H.R. 7120, the George Floyd Justice in Policing Act. 

    Rep. John Lewis Responds to Supreme Court Decision on Gay and Transgender Civil Rights

    June 15, 2020 Press Release

    WASHINGTON— “Today, the Supreme Court of the United States ruled in a 6-3 decision that firing an individual for being gay or transgender is a violation of title VII of the Civil Rights Act of 1964.  The Bostock v. Clayton County, Georgia decision addressed three cases where an employer filed a long-time employee based on their sexual orientation or gender identity.

  • Attorney General Barr Testifies on Justice Department Mission and Programs: Watch From the Beginning

    JULY 28, 2020

    Trump and Barr 

    Attorney General William Barr testified on the Justice Department’s mission and programs in an oversight hearing before the House Judiciary Committee; Wikipedia; this photo is taken at another unrelated ceremony.

    Watch live Watch from beginning 
     

    00:00:00  

    YES, GOOD MORNING. I HAVE BEEN A TEA PARTY PROTESTERS SINCE 2000 EIGHT, BEFORE PRESIDENT OBAMA TOOK OFFICE. [AMBIENT ROOM NOISE]
    00:00:04  

    THE HOUSE COMMITTEE ON THE JUDICIARY WILL COME TO ORDER. THE CHAIR IS AUTHORIZED TO DECLARE RECESS AT ANY TIME AND WE WELCOME, WE WELCOME EVERYONE TO THIS…

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    00:10:16  

    SPYING, THAT ONE WORD, THAT IS WHAT THEY ARE AFTER YOU FOR. 2019 IN A SENTENCE — PUTTING 19, YOU SAID THAT SPYING ON A POLITICAL CAMPAIGN IS A BIG DEAL. SPYING…

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    00:17:39  

    PEACEFUL PROTESTS.
    00:17:41  

    PEACEFUL PROTESTS.
    00:17:42  

    PEACEFUL PROTESTS.
    00:17:46  

    PEACEFUL PROTESTS.
    00:17:47  

    PEACEFUL PROTESTS.
    00:17:50  

    PEACEFUL PROTESTERS.
    00:17:52  

    I HAVE ASKED MYSELF, MY CHILDREN AND MY FAMILY, WE WOULD LIKE TO THANK FRIENDS, NEIGHBORS, COWORKERS, AND THE COMMUNITY FOR THE LOVE AND SUPPORT AFTER…

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    00:20:21  

    YEAH]>> OH, YEAH.
    00:20:22  

    TURN THE SOUND DOWN. [BARKING DOGS] [SHOUTING]
    00:20:52  

    TURN THE SOUND DOWN. [SHOUTING] [CHANTING] [SHOUTING]
    00:22:00  

    I HOPE MR. JORDAN WILL NEVER COMPLAIN ABOUT THE LENGTH OF MY OPENING STATEMENT. WITHOUT OBJECTION I WILL INSERT THE COMMITTEES AUDIOVISUAL POLICY INTO…

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    00:35:12  

    WE WILL NOW PROCEED UNDER THE FIVE MINUTE RULE WITH QUESTIONS AND I WILL RECOGNIZE MYSELF FOR FIVE MINUTES. ON JULY 22, YOU JOINED THE PRESIDENT AS HE…

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    00:36:01  

    OPERATION RELENTLESS PURSUIT TARGETED FAMILIAR LIST OF CITIES, PLACES LIKE ALBUQUERQUE, BALTIMORE COMING KANSAS CITY, CORRECT? A.G. BARR: CORRECT.
    00:36:12  

    AT THE SAME PRESS CONFERENCE, YOU CLAIMED 200 ARRESTS HAVE BEEN MADE UNDER OPERATION LEGEND. CORRECT. A.G. BARR: BUT YOU MISSPOKE — CORRECT.
    00:36:23  

    BUT YOU MISSPOKE. THE U.S. ATTORNEY’S OFFICE CONFIRMED ONLY A SINGLE REST HAD BEEN MADE UNDER THE AUSPICES OF OPERATION LEGEND. CORRECT? A.G. BARR: I DON’T…

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    00:36:34  

    THE 199 OTHER ARRESTS WERE MADE UNDER RELENTLESS PURSUIT OR OTHER PROGRAMS. A.G. BARR: THAT WAS CORRECT.
    00:36:42  

    I THINK YOU CAN BE FORGIVEN FOR BEING CONFUSED. OPERATION LEGEND APPEARS TO BE LITTLE MORE THAN A REPACKAGING OF EXISTING OPERATIONS. WHY ALL THE DRAMA? WHY…

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    00:39:07  

    YES OR NO. HAVE YOU DISCUSSED THE PRESIDENT’S REELECTION CAMPAIGN WITH THE PRESIDENT OR WITH ANY WHITE HOUSE OFFICIAL OR ANY CIRCUIT OF THE PRESIDENT? A.G.…

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    00:39:22  

    HAVE YOU DISCUSS THAT TOPIC WITH HIM? A.G. BARR: NOT IN RELATION TO THIS PROGRAM. I’M A MEMBER OF THE CABINET AND THERE IS ELECTION GOING ON. AUGUST WITH…

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    00:39:42  

    I DID NOT SAY I WAS SURPRISED. I ASK YOU IF YOU HAVE DONE THAT. IT IS PART OF THOSE CONVERSATIONS, HAVE YOU EVER DISCUSSED THE CURRENT OR FUTURE DEPLOYMENT…

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    00:39:55  

    IN CONNECTION WITH WHAT YOU JUST SAID. IN CONNECTION WITH YOUR DISCUSSIONS WITH THE PRESIDENT OR OTHER PEOPLE AROUND HIM OF HIS REELECTION CAMPAIGN, HAVE YOU…

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    00:40:18  

    YOU CANNOT TELL ME WHETHER YOU DISCUSSED — A.G. BARR: I WILL NOT TELL YOU WHAT I DISCUSSED WITH THE PRESIDENT.
    00:40:27  

    CAN YOU COMMIT IT WILL NOT USE THE FEDERAL GOVERNMENT AS A PROP FOR THE REELECTION CAMPAIGN? YOU CANNOT HIDE BEHIND LEGAL FICTIONS THIS TIME. PEOPLE SEE…

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    00:41:39  

    MY TIME IS EXPIRED. TO WHAT PURPOSE DOES MR. JOHNSON SEEK RECOGNITION?
    00:41:46  

    QUESTIONS FOR THE WITNESS. YOU HAVE CONFLATED TWO DIFFERENT THINGS. THE EFFORT OF LEGEND IS TO CONFRONT VIOLENT CRIME. PREDATORY VIOLENCE LIKE MURDER AND…

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    00:43:18  

    ON BEHALF OF HUNDREDS OF MILLIONS OF AMERICANS, THANK YOU FOR THAT CLARIFICATION AND FOR BEING HERE IN YOUR SERVICE TODAY AND YOUR WILLINGNESS TO DO THIS…

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    00:45:53  

    AMEN, AND THANK YOU FOR THAT. IN CONTRAST, WHAT THE PREVIOUS DOJ DID WAS POLITICIZE LAW ENFORCEMENT. THE OBAMA ADMINISTRATION’S APPETIZER — SABOTAGED…

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    00:46:49  

    IN YOUR OFFICE YOU ARE THEN FREE TO ACT INDEPENDENT OF THE PRESIDENT, ISN’T THAT CLUE — ISN’T THAT TRUE? A.G. BARR: IT IS TRUE, ESPECIALLY ON CRIMINAL…

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    00:47:00  

    THAT IS EXACTLY WHAT HE IS ASKED YOU TO DO.
    00:47:03  

    MS. LOFGREN?
    00:47:12  

    IT IS OBVIOUS WHAT IS HAPPENING FROM THE VIDEO PLAY ED. IT IS CLEAR THE PRESIDENTS PLAYBOOK IS TO DIVERT ATTENTION FROM HIS CATASTROPHIC FAILURE IN DEALING…

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    00:49:41  

    THE EXECUTIVE —
    00:49:43  

    THE EXECUTIVE ORDER THAT ASKED FOR THE DEPLOYMENT OF TROOPS TO PROTECT THE MONUMENT AND THE FEDERAL FACILITIES? A.G. BARR: I WOULD NOT SAY IT WAS TROOPS. WE…

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    00:50:16  

    WE CAN GET INTO THAT. I WOULD LIKE TO ASK YOU A QUESTION ABOUT SURVEILLANCE. WE READ A REPORT THAT STIMULATORS ARE BEING USED TO COLLECT PHONE CALL ROTATION…

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    00:51:05  

    I AM ASKING ABOUT AUTHORITY. A.G. BARR: MOST OF OUR CYBER ACTIVITIES ARE CONDUCTED BY THE FBI UNDER LAW ENFORCEMENT POWERS TO PROTECT AND DETECT FEDERAL CLIMB.
    00:51:18  

    I THINK THE AMERICAN PUBLIC SHOULD KNOW THAT THIS SURVEILLANCE TECHNIQUE — IF A HUSBAND-AND-WIFE CALL EACH OTHER AND ONE OF THE SPOUSES HAS A CELL PHONE…

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    00:52:15  

    THE GENTLELADY REAL DEALS BACK — THE GENTLELADY YIELDS BACK.
    00:52:21  

    CAN YOU ASK THOSE MEMBERS WHO CHOSE NOT TO COME TO WORK TO SILENCE THEIR CELL PHONES BECAUSE IT IS DISTRACTING?
    00:52:30  

    THAT IS NOT A POINT OF ORDER. I NOW RECOGNIZE MR. CAP. — MR. CABOT.
    00:52:37  

    WOULD IT BE ACCURATE TO SAY IT IS THE ADMINISTRATION’S RESPONSIBILITY TO SEE FEDERAL LAWS ARE UPHELD AND THE FEDERAL PROPERTY IS SECURE AND SAFE AND PROTECTED. IS…

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    00:54:06  

    THANK YOU. AS FAR AS WEAPONS AND DEVICES UTILIZED BY THE GROUP OF PEOPLE, YOU MENTIONED TRYING TO DESTROY THE COURTHOUSE. THEY WERE TRYING TO BURN IT DOWN. IT…

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    00:54:29  

    AS FAR AS THE WEAPONS YOU MENTIONED, MY UNDERSTANDING IS THE PEOPLE ATTACKING THE BUILDING HAD RIFLES, EXPLOSIVES, KNIVES, SAWS, SLEDGEHAMMERS, TASERS, ROCKS,…

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    00:55:28  

    IF LOCAL ELECTED OFFICIALS, MAYORS AND CITY COUNCILS AND GOVERNORS DID THEIR JOBS AND KEPT THE PEACE, WOULD IT EVEN BE NECESSARY FOR FEDERAL LAW ENFORCEMENT…

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    00:56:10  

    SOME HAVE DERISIVELY REFERRED TO THESE LAW ENFORCEMENT PERSONNEL AS STORMTROOPERS AND WORSE. DOES THAT ACCURATELY DESCRIBE THEM? WOULD YOU LIKE TO SET…

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    00:57:49  

    THANK YOU, GENERAL. MY TIME HAS EXPIRED.

  • Ferida Wolff’s Backyard, Appreciating The American Garden: Our Country’s Cactus; A Ride to Nowhere; Day Lilies and Deer

    Our Country’s Cactus

    cactus blossom

     
    Tucked away on the side of my house are some small cactus plants. They are normally fairly unobtrusive but when they put out their flowers, they are hard to ignore. The buds are big and the flowers are exuberant. I look forward to seeing them each summer.
     
    There are things to consider, however. A cactus plant has spines.  Spines can be stiff, hard,  or soft. They may be long or short. The spines on my cactus are so thin they can be ignored when I weed around the flowers. But they can’t be ignored for long. They push in under the skin and are uncomfortable reminders of not being careful in the garden. They cause sharp hints of pain until they are removed.
     
    This duality of beauty and pain is a reminder to me of what is going on nowadays. Underneath the beauty of our country lie the spines that effect so many of us. The pain caused by conquering, slavery, exclusion, and racism that has resurfaced in recent times all over America has been in us from the beginning but we haven’t been addressing the causes – until now.
     
    I hope that we are finally becoming able to appreciate our incredible diversity, to value the beauty that all people bring and to take out the spines that discrimination has implanted in our country’s body. Only then will we be able to truly appreciate our amazing American garden.
     
    My cactus – the Eastern Prickly Pear:
     

    A Ride to NowhereA Ride to Nowhere

     
    During this time of pandemic, my husband and I sometimes take car rides to nowhere to get us safely out of the house. We drive through local places we haven’t explored yet, looking at the vegetation and the houses, getting a general feeling for the area. Sometimes, if there aren’t any people around, we’ll take a short walk through a nature setting and enjoy the birdsongs that float out of the trees.
     
    We recently came upon a local setting that was so peaceful, we had to stop.  A softly flowing lake beckoned on this hot day. Gentle waves moved slowly in the breeze. It was a welcome  environment where we could, for the moment, forget about what was going on in the world and take some deep, rejuvenating breaths.
     
    It’s necessary to balance personal needs with a broader awareness of our safety and the safety of others. We would love to go to museums and theaters and concerts but that is not yet feasible. So we do what we can to find the positive in this difficult time; taking a ride to nowhere helps.
     
    Former monk Jay Shetty offers help on how to deal with this pandemic:
    July 27, 2020