What 'safe and effective' really means

Eliyahu Tulshinski

February 20, 2024

Never 100% safe

Public health officials were recently grilled in several congressional hearings for giving the impression that COVID mRNA injections were 100% safe and effective, as covered in “When public hears 'safe and effective' they hear '100% safe and effective' - Congressman Brad Wenstrup.” Dr. Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research, was forced to admit, "No pharmaceutical is a hundred percent safe."

What safe really means

In fact, his agency's website specifically qualifies what is meant by "safe":

Drugs approved by the U.S. Food and Drug Administration (FDA) for sale in the United States must be safe and effective - which means that the benefits of the drug must be greater than the known risks. However, both prescription and over-the-counter (OTC) drugs have side effects. [Emphases added.]

The FDA thus uses a formula in which the expected benefits of a drug are compared to expected adverse effects, both of which may be manipulated.

Manipulating data

The problem here is that painting a complete picture of the benefits and risks for any disease is a highly subjective process, even though medicine is supposedly a science. Gaining an accurate impression of the true case-fatality rate for COVID specifically proved extremely difficult, because so many cases were asymptomatic and were therefore never recorded as cases at all. Sidelining this considerable issue, public health authorities simply used the diagnosed case-fatality rate, meaning that COVID appeared much more fatal than it actually was.

Furthermore, many “COVID deaths” were nothing of the sort; all the death certificate meant was that a person who passed away from, for example, late stage cancer, happened to test positive for COVID at some point during their hospital stay, even if they lived longer than expected.

Once contracting COVID had been “demonstrated” to mean a significant risk of dying, it was relatively simple to “demonstrate” that despite the risks associated with the shots, the benefit made them worthwhile.

Adverse event rates are also easy to manipulate, as became evident in the labeling of post-vaccine myocarditis as a complication of ‘Long COVID.’ Such manipulation was also seen in Pfizer's reporting from their mRNA shot's clinical trials, where of a young girl who wound up on a feeding tube and in a wheelchair was listed as having suffered from a “stomach ache.”

When drug side effects look like the disease the drug is treating

More distortions enter the picture when a drug's side effects include the very symptoms they are meant to prevent or alleviate. This is far more common than many people realize. Anti-inflammatories can cause inflammation. Polio vaccination causes more polio infections than wild virus. Anti-depressants can cause suicidal thoughts. Chemotherapy can cause cancer. Will a chemotherapy-induced cancer be recorded as a side effect of chemotherapy (raising its risk profile) or will researchers assume that the cancer occurred despite the treatment (perhaps blaming it on genetic markers)?

Statistics that lie

The result of all these manipulations and misinterpreted side effects is that a pharmaceutical may be considered safe and effective only because the disease it is supposedly protecting a person from is overblown, while serious adverse effects are falsely blamed on other conditions or simply listed as benign conditions like stomach aches.

In practice

As an example of an unsafe pharmaceutical deemed safe, if a virus is associated with an additional 5 deaths in 100,000 people but 100 in 100,000 people die with a positive test for the virus (but not from the virus), the death rate from the virus will be calculated as 100 in 100,000.

And if a pharmaceutical to treat or prevent that same virus is associated with an additional 100 deaths in 100,000 people, but only 5 of those deaths are officially listed as deaths caused by the pharmaceutical, the death rate from the pharmaceutical will be calculated as 5 in 100,000.

In reality, the pharmaceutical is 20 times more dangerous than the virus, but will nonetheless be considered 20 times safer than not taking it.

Check back for the next installment of our series of drug side effects and see our previous coverage of COVID and the mRNA injections: