Gates Package — page 692

there was no evidence to suggest ivermectin could be used to successfully prevent COVID-19 infection. In August, 2021, the IDSA issued a joint statement with the HIV Medicine Association and the Society for Healthcare and Epidemiology of America recommending against the use of ivermectin for the treatment of COVID-19 and determined the certainty of evidence is very low for both hospitalized patients and outpatients. For this reason, the panel made a conditional recommendation against the use of ivermectin outside the context of a clinical trial."11,12 The Centers for Disease Control and Prevention (CDC) in August 2021 issued a health advisory warning physicians and the public about the rise in prescriptions for the anti-parasitic drug ivermectin for use in the treatment or prevention of COVID-19.13 The U.S. Food and Drug Administration echoed the CDC's warning against the use of ivermectin for prevention or treatment of COVID-19 and refused to authorize or approve the drug for such purposes.14, 15 On December 8, 2020, the Senate Homeland Security and Governmental Affairs Committee held a hearing titled, "Early Outpatient Treatment: An Essential Part of a COVID-19 Solution, Part II," to discuss early outpatient treatments for COVID-19 using widely available, safe and low cost drugs, including ivermectin. Physicians testified that early outpatient treatments like ivermectin could possibly save hundreds of thousands of lives.16 Pursuant to the Freedom of Information Act (FOIA), 5 U.S.C. § 552, and the implementing regulations of your agency, 45 C.F.R Part 5, Children's Health Defense (CHD), a non-governmental organization, makes the following request for our records. 16 See https://www.hsgac.senate.gov/imo/media/doc/40-317_Comm.%20Homeland%20Security%20%20Gov.% 20Affairs%2012-10-2020.pdf, (last accessed March 7, 2022). 15 Sara Berg, MS, Why ivermectin should not be used to prevent or treat COVID-19 https://www.ama-assn.org/delivering-care/public-health/why-ivermectin-should-not-be-used-prevent-or-tre at-covid-19, (last accessed March 7, 2022). 14 See https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-c ovid-19, (last accessed March 7, 2022). 13 See https://emergency.cdc.gov/han/2021/pdf/CDC_HAN_449.pdf, (last accessed March 7, 2022). 12 See https://www.idsociety.org/practice-guideline/covid-19-guideline-treatment-and-management/, (last accessed March 7, 2022). 11 See https://www.idsociety.org/globalassets/idsa/public-health/covid-19/final-ivermectin-joint-statement-dsw-aw -fc_bda_tf-laj.pdf, (last accessed March 7, 2022).