Comment from Mark Obermeyer

The COVID-19 Emergency Use Authorization for off-label use of nasopharyngeal swabs on asymptomatic subjects should have followed &quot;Master Protocols for Drug and Biological Product Development Guidance for Industry&quot; to identify and quantify any medium and long term adverse events.<br/><br/>Instead FDA depended solely on the &quot;grandfathered&quot; incorrect classification of this device and procedure as being &quot;Class I&quot;, along with a few hastily prepared retrospective literature reviews tallying immediate adverse events that required further interventions.<br/><br/>The EUA was granted despite these literature reviews commonly including severe epistaxis (nosebleed) requiring packing, demonstrably in the presence of SARS-CoV-2 virus pathogen for any tests which returned a positive result. This glaring red flag of frequent, virtually guaranteed blood contact with a viral pathogen was ignored. Minor nosebleeds are not even reported as adverse events due to the mis-classification as Class I.<br/><br/>Normally, FDA would demand Randomized Controlled Trials for such an off-label use. I cannot, however, recommend RCTs on ethical grounds. The evidence I present demonstrates to my satisfaction that the nasopharyngeal swab device is deadly.<br/><br/>My MAUDE report of the consequences of swabs damaging the nasopharyngeal mucus, epithelial cells and associated blood vessels, and in the process, causing direct contact of the SARS-CoV-2 and other virus pathogens was downplayed and then ignored, despite having been escalated to the highest levels of the FDA, US Surgeon General and other pertinent agencies such as HHS, CDC, WHO, international public health agencies, etc.<br/><br/>Worse, when repeatedly informed of my findings, the CDC first obfuscated, and then completely hid the CDC COVID Data Tracker data.<br/><br/>Attached to this comment are just a few examples of my correspondence to various FDA staff over a period of several years, illustrating my persistent efforts to bring FDA&#39;s non-compliance with their own &quot;Master Protocols&quot; to light.<br/><br/>Also attached are pre-print papers on the topic. I have been unable so far to find a journal willing to publish or even so much as peer review these analyses. The problem is that many epidemiologists worldwide are now highly conflicted, having participated in demanding what amounts to a massive and deadly uncontrolled public health experiment, just to gather more and more data. Data which is still being ignored and is now hidden and covered up by CDC.<br/><br/>Also attached are copies of other recent Comments I have made.<br/><br/>Also attached, as a hopefully permanent public archive, are some of the latest publicly available data files downloaded directly from the CDC COVID Data Tracker without any alteration. Data is for Weekly Deaths, Weekly Test Volume and Weekly Test Positivity for all 10 HHS Regions and the US as a whole, spanning the duration of the COVID-19 pandemic.