Source: Trial Site News
While vaccines have made up much of the COVID-19 headlines and represent an instrumental strategy in the long-term fight against COVID-19, so do antiviral therapies as the U.S. government recently proclaimed with a $3+ billion announcement to focus on these treatments moving forward. TrialSite’s followed the ivermectin story since April 2020 and has chronicled many of the 60 studies from all over the world. The majority of the studies produced positive data, albeit a couple generated neutral but not negative results. Several locales authorized the use, mostly low-to middle-income countries (LMICs), and the world’s second-most populous country saw some of its states use the therapy effectively in a population-wide scheme.
Enormous pressure built up from a combination of a powerful lobby consisting of industry, government, and academia to repress the use of this drug for a confluence of reasons. But the use goes on and grows as a defensive precaution in many locales, such as in the richest state in the world’s fourth-biggest economy as measured by GDP—Germany. While ivermectin not authorized in Germany for the COVID-19 indication, in Bavaria, TrialSite’s community is active and sends updates, including the use of the drug by some physicians at a major academic medical center in Munich.
For example, the chief doctor and anesthesiologist in intensive care, Dr. Franz Brettner at the academic medical center known as the Barmherzige Bruder Hospital in Munich, affiliated with the University of Munich and the German Academy for Nutritional Medicine, reports that the use of ivermectin targeting COVID-19 has made a material difference in the lives of patients.
As the drug isn’t approved for this indication, its use is done via the traditional off-label approach where the physician and the patient both agree on the approach after reviewing risks and benefits.
Dr. Brettner shared with Bavaria TV Live that in some cases when their protocol merits, they may treat the hospitalized COVID-19 patient with ivermectin and corticosteroids. Interestingly, the doctor reports that the hospital has seen dramatically better results for moderately to severely ill COVID-19 patients under this protocol.
This German TV entry also shared the perspective of a physician practicing in the upscale Bogenhausen district of Munich. According to the show’s translation, Dr. Peter Schleicher, purports to be an expert in ivermectin that used the drug for three decades.
Pointing out the drug’s safety, this German physician suggested that where it’s in use, the incidence of COVID-19 goes down. He emphasized recent meta-analyses, such as the recent one authored by Dr. Tess Lawrie and team in the American Journal of Therapeutics sharing that dozens of randomized controlled trials, not to mention numerous observational studies, indicate positive evidence using rigorous medicinal evidence-focused analytical methodologies.
In Germany, ivermectin is known as Driponin. An economical generic drug, its safety profile is compelling on label with multiple billions of doses of evidence across four decades in LMICs, predominantly in Africa.
TrialSite shares a European “Public Assessment Report” covering this German generic form of Merck’s Stromectal registered in the EU since 2003.
In 2019, the decentralized procedure shared the similarity between the branded and generic ivermectin versions, thus earning market authorization. Driponin is produced by Substipharm, a generic pharmaceutical company headquartered in Paris, France.
A Point of View
Around the globe, networks of physicians communicate and collaborate in hospitals, clinics, and medical offices to help patients overcome COVID-19. During the pandemic, groups such as the Front Line COVID-19 Critical Care Alliance (FLCCC) and others helped organize these networks to disseminate important information about treatments such as ivermectin that were censored via the primary communication channels of today—the tech social network giants of Facebook, Google (YouTube) and Twitter. TrialSite has been directly censored by these organizations for no apparent reason. As TrialSite has pointed out, a confluence of forces such as government, public health heads, industry, and media came together to establish what was “truth” versus “misinformation.”
While, undoubtedly, there were good intentions for many behind this mass communication initiative, it became a vehicle for regulatory capture, as even truthful journalism was suppressed. For example, just the word ivermectin could trigger the censorship algorithms. No doubt there has been some collective move to suppress cheap generic approaches despite the mounting evidence of positive data. While the National Institutes of Health (NIH) has finally included an ivermectin study (ACTIV-6), this was quite late given the pandemic’s devastation and the mounting evidence, including a meeting with the FLCCC in January 2021.
In America, a principal investigator and study team strive to complete a study and impact COVID-19 early-onset care via the COVID-Out study. Led by the University of Minnesota’s Carolyn Bramante, the study seeks patients and partnering clinics to participate in a trial that ships the drug same day to patients that fit the inclusion and exclusion criteria. Although there is a placebo, a sizable percentage of participants receive study drugs. This study is backed by UnitedHealthcare. America’s largest payer would benefit if a low-cost therapy addressing COVID-19 were formally authorized by the FDA.