by Dr Simone | May 26, 2025 | Big Pharma, Bioweapon, Cancer, CDC, Children, CORONAVIRUS, COVID-19, Dr Simone, Dr Simone Report, FDA, Innate Immunity, Myocarditis, VACCINE
Because of President Trump’s Restoring Gold Standard Science Executive Order (binding within 30 days), I am convinced that he will adhere to the scientific and legal definition of a vaccine – as defined by the CDC, FDA, NIH, NIAID, NCI, U.S Patent Office, and Ninth Circuit Court – A VACCINE MUST PREVENT THE DISEASE AND PREVENT ITS TRANSMISSION – the mRNA gene therapy INJECTION DOES NEITHER – a salient fact arbitrarily and capriciously ignored by FDA’s Drs Prasad and Makary thus defying President Trump’s Executive Order, the Ninth Circuit’s ruling, agencies and Institutes, and thereby putting 100-200 million Americans at risk.
Regardless of age, the COVID shots will not help anyone with other risk factors because it will not prevent them from getting COVID nor will it prevent them from transmitting COVID.
The harm from these shots is real and the shots cannot be justified given the low fatality rate of COVID. This gene therapy must have different guidance and thresholds for market approval.
Since COVID-19 injections are not vaccines, the precedent set by Jacobson v. Massachusetts, allowing compelled vaccination, is irrelevant.
Instead, the Supreme Court’s ruling in Cruzan v. Director, Missouri Department of Health, which protects the right to refuse medical treatment, would apply. The federal government lacks a basis to mandate COVID-19 injections for employment or service, and the mandated childhood COVID-19 injections for school violates the right to refuse medical treatment recognized in Cruzan.
by Dr Simone | May 14, 2025 | Dr Simone, Dr Simone Report, Drugs, FDA, Healthcare, Healthcare Costs, TELEHEALTH
Current rules from the FDA apply to drug companies’ ads, requiring them to show risks. But telehealth companies aren’t held to the same standards — even when they promote the same drugs. That could mislead patients.
Are doctors favoring drugs from partner companies?
Are patients being properly evaluated?
What exactly are the companies paying each other for?
Is the Anti-Kickback Statute (AKS) being violated?
by Dr Simone | Apr 1, 2025 | CDC, Charles B SimoneMD, Children, CORONAVIRUS, COVID-19, Dr Simone, Dr Simone Report, FDA, The Simone Report, VACCINE
In a decision that has ignited fierce debate, Susan Monarez, PhD, Acting Director of the U.S. Centers for Disease Control and Prevention (CDC), recently endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation to vaccinate children aged 5-11 against COVID-19 with the Pfizer-BioNTech pediatric vaccine. Announced in late 2021 and reinforced through ongoing CDC guidance, this move extends vaccine recommendations to over 28 million children nationwide, authorizing providers to begin administering the shots. At first glance, it might seem like a standard public health strategy to combat a global pandemic. Yet, a deeper dive reveals a troubling rift between this policy and the scientific evidence—a rift that Monarez and the ACIP appear to have overlooked, potentially undermining the very mission they are sworn to uphold.
by Dr Simone | Nov 12, 2018 | Charles B SimoneMD, Dr Simone, Dr Simone Report, FDA, Opioid Crisis
Fire FDA Commissioner Dr. Scott Gottlieb because even in the face of the most severe opioid crisis in America and against the advice of experts, he approved another opioid painkiller Dsuvia (made by Big Pharma’s AcelRx) that is 10 times more powerful than fentanyl and 1,000 times more powerful than morphine, and provides no new benefits. The potential for abuse is enormous. He used our wounded warriors on the battlefield to defend his approval. The fact is, we have plenty of pain medications for our wounded warriors that have been thoroughly reviewed by our military, Tactical Combat Casualty Care.
by Dr Simone | Oct 1, 2018 | Antidepressants, Charles B SimoneMD, Dr Simone, Dr Simone Report, Psychiatric Medicines, Violent Behavior
You the taxpayer through Medicaid, paid $366 million for these medications that are not effective and can induce violent behavior.
