Real World Evidence? #I-MASK+ Protocol: #Ivermectin Key for Prophylaxis and Early Treatment of #COVID-19:
Real world evidence (RWE) means medical evidence obtained from real world data (RWD), that is observational data, secured from outside the context of clinical trials and rather produced during routine clinical practice. The 21st Century Cures Act, enacted as law in 2016, heavily supported by the pharmaceutical industry, mandated the use of Real World Evidence (RWE). The intention of the Act largely was to expedite the approval process including easing the requirements placed on clinical trial sponsors seeking U.S. Food and Drug Administration (FDA) approval on new products or new indications on existing drugs. For example, the new ACT supported a company to provide “data summaries” and “real world evidence”, such as observational studies, insurance claims data, patient input, rather full clinical trial results, at least in certain situations. With its passing, the FDA embraced RWE, noting that RWE and RWD are playing an increasing role in health care decisions. With the onset of the COVID-19 pandemic, a collaboration in Australia led by Monash Universit y identified in a lab that an approved FDA drug, one with a well-established safety record, Ivermectin, is actually an inhibitor of the causative virus (SARS-CoV-2). They reported that in vitro there was a ~5000 fold reduction in viral RNDA at 48 hours. The rest is history as TrialSite has chronicled now the many dozens of case series, observational studies, a couple completed studies with randomized components, and in the aggregate off-label use cases in many countries around the world. A couple Ivermectin studies have surfaced in reputable peer review medical journals. Why put so much attention into the topic? There is a deadly pandemic that isn’t slowing down. In addition to the critical research supported by the pharmaceutical industry and National Institutes of Health (NIH), physicians seek to save lives in the present moment. Given Ivermectin was already FDA approved and in fact does have a well-known safety profile, could it in fact fall under the Act for purposes of accelerating FDA approval as part of some combined therapy? As that question may soon be pondered, the pandemic worsens. Enter groups of physicians such as the Front Line COVID-19 Critical Care Alliance (FLCCC).
Small Tribe in Pacific Northwest Drop AZD1222 & Seek Participation in Novavax COVID-19 Vaccine Clinical Trial:
What does a niche vaccine-focused biotech from Gaithersburg, MD toiling in relative obscurity for years and a small Native American nation in the far Pacific Northwest have in common? COVID-19. A piece in Science recently suggested that the once small American vaccine development company, Novavax just a year ago toiling in obscurity—yet today slated to receive up to $2 billion from the U.S. government and others to develop and manufacture their moth cell-based COVID-19 vaccine—may actually be on to one of the most superior vaccine candidates. Why? Author Meredith Wadman suggests that their investigational vaccine candidate thus far outperforms most others when factoring in key measures on monkey and early-stage human studies. So how do the Lummi (Lhaq’temish or People of the Sea) fit into this picture? This Native American group, situated in the far Pacific Northwest at the Canadian border, represented by the Lummi Public Health Department, recently submitted an application to participate in the Novavax COVID-19 vaccine trial.