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Health See other Health Articles Title: FDA drug safety expert Dr. David Gortler: Vaccine manufacturers, FDA not adequately warnings about myocarditis risks The FDA's VAERS database shows a long and impersonal number of deaths from heart conditions in young healthy people. America has a list of over 700,000 reports of adverse events, but it's difficult to understand the humanity of large numbers of serious adverse events, especially cardiovascular adverse events, which many people do not realize were clearly warned about in the FDA medical review of the Pfizer application. We don't always know the specific details about those who died, including their ages. To give some perspective, I've compiled a list of seemingly healthy people who died or suddenly, devastatingly collapsed, as reported in the news just since December 1, 2021. Most are young athletes in the prime of their careers. The list is shamefully long and deeply depressing. So as not to interrupt the flow of this post, you'll find the list at the bottom. What's patently clear is that there is a mysterious increase in younger college and professional athletes fainting, having heart attacks, and suffering deaths potentially related to cardiovascular adverse events following mRNA vaccines. In many cases, the reports do not mention the athlete's vaccine status. Admittedly, these are poorly documented anecdotal cases because they are not collected by regulatory or medical professionals. However, the sheer number of cases, something we've never seen before, is cause for alarm to drug safety experts like myself. Myocarditis and pericarditis used to be considered rare conditions. They are defined as inflammation of the heart muscle or layers of the pericardial sac, respectively. Both conditions cause easily recognizable ECG changes and have nonspecific symptoms that include shortness of breath and chest pain. They can easily be diagnosed clinically with echocardiograms and can easily be treated by pharmacology. The FDA's medical officer review, which was the basis for approving the Pfizer vaccine, notes that "clinically important serious adverse reactions [were] anaphylaxis and myocarditis/pericarditis." These are also just cardiovascular cases. According to Steve Kirsch, intracranial infection cases are up 60-fold since vaccines rolled out. Additionally, there have been over four dozen cases of sudden onset of acute transverse myelitis following mRNA COVID-19 vaccination. Image: Qatar pro-soccer player Othman Coulibaly suffered a heart attack. YouTube screen grab. The information I gathered for the list, below, comprises individual stories I was able to data-mine from the news. Additionally, there are thousands of reports of heart attack/myocarditis/pericarditis in the USA alone. Moreover, these thousands of cases are well known to represent only 1–10% of the adverse events that occur in actuality. It's very unlikely that these heart-related deaths in young healthy individuals are random phenomena. Pfizer should already have placed a substantial warning on the label. Additionally, the FDA, major pharmacies, and state pharmacy boards should have loudly warned pharmacists to comply with their federal Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requirements. Had they complied, they would have warned all their patients about potentially deadly cardiovascular adverse events, as well as other adverse events trending upward in VAERS that are associated with COVID vaccine and booster administration. Even as the list of victims of the vaccine grows longer, the entire federal government and mainstream media fail to report the vaccine's shortcomings. They are shamefully complicit in ignoring science and endangering us all. Dr. David Gortler is a pharmacologist, pharmacist, and FDA and health care policy scholar at the Ethics and Public Policy Center think-tank in Washington, D.C. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served at Yale's Bioethicist Center, and was an FDA medical officer who was later appointed by the White House to serve on the FDA's Senior Executive Leadership Team as senior adviser to the FDA commissioner for drug safety, drug epidemiology, FDA science policy, and FDA regulatory affairs. He is a regular columnist at Forbes and writes on drug safety, health care, and FDA policy. Sudden, unexpected heart attacks and deaths in the seemingly healthy over the past 45 days Post Comment Private Reply Ignore Thread
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