Corona keeps giving and giving: https://arstechnica.com/science/202...-us-mink-farms-unusually-larger-numbers-dead/
Death toll mounts as FDA denies HCQ for outpatient therapy On Aug. 10 the FDA denied the urgent request for emergency approval for COVID-19 outpatient preventive and early treatment use of hydroxychloroquine (HCQ) filed July 1 by Dr. John McKinnon's team at Henry Ford Hospital in Detroit, supported by Dr. Peter McCullough's cardiology team at Baylor Heart and Vascular Institute in Dallas. Approximately 48,000 more Americans have died during the FDA's 48-day delay since this Emergency Use Authorization (EUA) was requested on July 1. Dr. McKinnon's clinical trial found an impressive 51% reduction in deaths if HCQ was begun within 24 hours of admission to the hospital. An outpatient primary care study by Dr. Vladimir Zelenko, using HCQ, azithromycin and zinc given within less than seven days of COVID-19 symptoms, showed approximately 80% decrease in deaths, and less than 1% of his patients needed to be hospitalized. These extraordinary results show how many lives can be saved with early HCQ treatment. Advertisement - story continues below Dr. Harvey Risch, Yale epidemiologist, projected that widespread early treatment for COVID-19 with HCQ could have saved 100,000 American lives. The physician head of the FDA, Dr. Steven Hahn, has again betrayed physicians and patients by preventing Americans from having the "right to try" HCQ for early COVID-19 treatment. Dr. Hahn knows full well the FDA approved HCQ as safe in 1955, and it has been used in millions of patients worldwide for 65 years with an impressive track record of safety in patients of all ages, all ethnic groups, and even pregnant women and nursing mothers. / Loaded: 100.00% The FDA's denial of the EUA for early outpatient COVID-19 use of HCQ continues the agency's false narrative in claiming outpatient harm for HCQ, based on inpatient data in critically ill patients. Dr. Hahn has ignored established facts of effectiveness and lack of harm for outpatients that have been established in more than 50 recent studies. A newly released study from Turkey found no cardiac abnormalities with HCQ given at therapeutic doses for five days in early COVID patients. Attributing any late-stage cardiac effects to HCQ that is known to be caused by the virus and inflammatory damage is indefensible. Advertisement - story continues below What amount of "data" will ever satisfy Dr. Hahn? The FDA used a standard of "may be effective" for the rapid May 1 EUA given to the experimental anti-viral remdesivir, based on one controlled clinical trial terminated early. Yet FDA is now requiring a higher standard of a randomized controlled clinical trial for the already FDA-approved HCQ in safe use for 65 years. Remdesivir showed very little benefit shown in hospitalized COVID patients and had serious side effects. Nine of the members of the NIH panel relied on for COVID treatment advice were supported financially by Gilead Sciences, maker of remdesivir. As a cancer specialist, Dr. Hahn knows early treatment of any disease is critical, especially viral illness. But it is more critical with COVID-19, or SARS CoV-2, as we learned in 2005 when National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) published their studies from the 2002 outbreak of the closely related SARS-CoV-1 virus. These laboratory tests of possible anti-viral medicines clearly showed potent antiviral effects of chloroquine (CQ) against SARS-CoV-1 to block the SARS-CoV-1 infection at the earliest stage. Dr. Fauci was at NIH them, so he has known about this work for more than 15 years. From these studies we know that HCQ with zinc works during the first five days to stop viral entry into our cells and to block the virus from multiplying. Without HCQ and zinc, by day six or seven the viral load explodes and then triggers an exaggerated inflammatory response. This "cytokine storm" can severely damage critical organs: lungs, kidneys, heart, brain, liver and intestines and is often fatal. Advertisement - story continues below Earlier this year, Dr. Peter McCullough's team showed prophylactic benefits of HCQ given to hospital workers who were exposed to COVID daily in their work, just as found in India, South Korea, China and multiple other countries. This preventive benefit of HCQ given once a week could protect front-line medical workers, law enforcement officers, paramedics, clergy, dentists/dental hygienists, truck drivers, food-processing workers, teachers, behavioral health professionals, factory and grocery store workers, flight attendants and many others. We could more safely reopen America's businesses, schools and churches with doctors and patients having widespread, early access to HCQ. Doctors treating COVID-19 patients NOW see lives being saved by cheap, safe, FDA-approved medicines – hydroxychloroquine with azithromycin or doxycycline, plus supplemental zinc, vitamin C and vitamin D. Why don't Americans have the freedom to use HCQ here as in other countries? The FDA's misleading statements about HCQ have led to dangerous, unprecedented restrictions on physicians' off-label prescribing rights imposed by state governors, medical boards and pharmacy boards. The supply of HCQ has been ramped up to handle its use in early treatment of COVID. The Strategic National Stockpile has millions of doses deteriorating in government warehouses that are not being distributed because doctors are prevented for political reasons from prescribing for outpatients with COVID-19. Advertisement - story continues below Americans are dying needlessly for political and financial agendas waiting for the "magic bullet" of a vaccine, not due to lack of available treatment for COVID-19. We still need therapeutics, such as HCQ, even if a vaccine works and is safe. Testing is inaccurate and often unavailable, and HCQ dispensing must not be limited to persons with a positive test. Such limits also prevent prophylactic use. Governors and bureaucrats must not be allowed to arbitrarily restrict life-saving HCQ treatment. The Fauci-Hahn strategies of suppressing the positive studies of HCQ effectiveness for outpatient use, while focusing on mandatory mask edicts and continued shutdowns of businesses, schools and churches are not controlling the pandemic. These political agendas have eroded our constitutional freedoms and devastated our financial, psychological, physical and spiritual well-being – while costing 1,000 American lives every day. Dr. Hahn needs to be held accountable for the preventable deaths caused on his watch. As a physician licensed in three states that prevent prescribing HCQ for my patients, I submitted a formal request to the chairman of Senate Oversight Committee on Homeland Security and Governmental Affairs (HSGAC) for Dr. Hahn to be called before the Committee to produce the data on which the FDA is claiming "harm" in using HCQ for outpatients in the mild stage of COVID, but no such harm for RA, Lupus, or malaria. FDA's hypocrisy ignores their own safety data, basic science, clinical studies and common sense. Advertisement - story continues below Americans must speak out and demand the medical freedom to consult their physicians and decide treatment options without government interference. Written by: Elizabeth Lee Vliet, M.D. Summary Recent Posts Contact Elizabeth Lee Vliet, M.D. is the founder of Vive Life Center independent medical practice in Tucson, Arizona, and Dallas, Texas, specializing in preventive and climacteric medicine with an integrated approach the treatment of women and men with complex medical-endocrine problems from puberty to late life. Dr. Vliet is a 2014 Ellis Island Medal of Honor recipient for her national and international educational efforts in health, wellness, and endocrine aging, recognized in the USA as a powerful patient advocate, and proponent of free market approaches to lower health care costs. Dr. Vliet is a recipient of Voice of Women Award from Arizona Foundation for Women, the author of seven consumer health books and a past Director of the Association of American Physicians and Surgeons (AAPS).
HOME ABOUT SUBMIT NEWS & NOTES ALERTS / RSS Search for this keyword Advanced Search Comment on this paper Hydroxychloroquine Safety Outcome within Approved Therapeutic Protocol for COVID-19 Outpatients in Saudi Arabia Abdulrhman Mohana, Tarek Suliman, Nagla Mahmoud, Mustafa Hassanein, Amel Alfaifi, Eissa Alenazi, Nashwa Radwan, Nasser Alkhalifah, Ehab Elkady, Abdullah Almohaizeie, Fouad AboGazalah, Khaled AbdulKareem, Fahad AlGhofaili, Hani Jokhdar, Fahad Alrabiah doi: https://doi.org/10.1101/2020.08.16.20175752 This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice. Abstract Info/History Metrics Preview PDF Abstract Background: Healthcare systems globally has been challenged following the COVID-19 pandemic, since late 2019. Multiple approaches and strategies have been performed to relieve the pressure and support existing healthcare systems. The Saudi Arabian Ministry of Health (MOH) launched an initiative to support the National Healthcare System. Since the 5th of June 2020, 238 outpatient fever clinics were established across Saudi Arabia. Methods: A cross-sectional study included 2,733 eligible patients subjected to MOH treatment protocol (hydroxychloroquine and zinc) and revisited the clinics within 3-7 days after treatment initiation. This study aimed to assess the safety outcome and reported adverse events from hydroxychloroquine use among suspected COVID-19 patients. The data was collected through an electronic link and cross-checked with that of the national database (Health Electronic Surveillance Network, HESN) and reports from the MOH Morbidity and Mortality (M&M) Committee. Results: Majority of the cases were males (70.4%). Upon reassessing the studied participants within 3-7 days, 240 patients (8.8%) discontinued the treatment protocol because of the development of side effects (4.1%) and for non-clinical reasons in the remaining (4.7%). Medication side effects overall were reported among (6.7%) of all studied participants, including mainly cardiovascular adverse events (2.5%), followed by gastrointestinal (GI) symptoms (2.4%). No Intensive Care Unit (ICU) admission or death were reported among these patients. Conclusion: In our study, results show that the use of hydroxychloroquine for COVID-19 patients in mild to moderate cases in an outpatient setting, within the protocol recommendation and inclusion/exclusion criteria, is safe, highly tolerable, and with minimum side effects. Competing Interest Statement The authors have declared no competing interest. Funding Statement This research is of an ongoing project at Saudi Arabia Ministry of Health. No external funding were obtained. Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Saudi Arabia Ministry of Health IRB committee review, approved, and continuously audit this research All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
These will be the countries that are not prepared for the world to reopen. Sweden did it right and got it over with quickly. Brazil in the midst of that now as well as some Red States.