Pharmafiles News 🍍 September 13, 2023 🍍 Shocking FDA incompetency recorded on tape!

FDA Minimizing Serious Adverse Events using Observational Data! FDA unaware of Cardiac Arrest and death of a 7-year-old after vaccination!

Greetings, my friends! Today, we will break down the recent revelation of an audio recording captured behind closed doors, in which FDA officials brushed off discuss the findings of serious adverse events.

🍍FDA Minimizing Serious Adverse Events using Observational Data!

An audio recording of a meeting with high-level FDA officials has surfaced, shedding light on some shocking incompetence within their ranks. It's understandable that not everyone is familiar with the intricate details, so let me break it down in a more relatable way for us regular folks.

Dr. Joseph Fraiman and his colleagues engaged in discussions with the FDA to deliberate on the findings presented in the research conducted by Fraiman et al.

In summary, the study conducted by Fraiman and his team revealed a notably higher incidence of serious adverse events, with a rate of at least 1 in 800 among the vaccinated population.

Serious adverse events (SAEs) are defined as significant outcomes that occur following vaccination. These events include:

1. Death

2. Life-threatening conditions

3. Hospitalization or prolongation of existing hospitalization

4. Persistent or significant disability/incapacity

5. Congenital anomalies or birth defects

6. Medically important events that require medical or surgical intervention to prevent any of the above outcomes.

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In the FDA meeting, when discussing Dr. Fraiman's findings, the officials disregarded them, claiming that "Real World Data" didn't match their findings. However, it's important to note that there is a significant difference between "Real World Data" (also known as "Real World Evidence") and the findings from clinical trials.

Let's consider an analogy to better understand this distinction.

Think of clinical trials as a carefully organized apple-picking contest. Contestants are positioned in an orchard, each assigned a specific tree, and everything is planned and controlled. There are rules, timers, and judges to ensure fairness and accuracy.

In contrast, “real-world data” is akin to casually observing people picking apples in their own backyards. It's like quietly watching your neighbors' apple trees and attempting to glean insights from their various picking styles.

The FDA Official seemed to disregard the findings of Dr Joseph Fraiman and colleagues regarding their reanalysis of Pfizer's own clinical trial data by simply stating, "Oh, what we observed in the real world doesn't line up with your findings." It's frustrating to see such incompetence!

During my time working in Pharma, we sometimes used "Real World Data" to influence doctors into prescribing our medications more frequently. In the field of sales, Pharma typically adopts a sales technique called "The Challenger" due to the complexities involved in selling drugs (which is different from selling beverages like beers).

For instance, if a doctor expresses concerns about the effectiveness of your vaccine, one approach to address their concerns is by presenting "Real World Data". For example, you can share the observation, "Did you know that in another hospital, we noticed a lower number of vaccinated individuals in the intensive care units?" This information is intended to reframe the conversation by basically moving away from one dataset that the doctor used to express their concerns and potentially influence their perception of the vaccine's efficacy.

If you want a deeper understanding of why certain doctors argue that unvaccinated individuals are being admitted to ICUs based on real-world data, I recommend reading the article titled "The Pachinko Machine Effect and the Death Loop". It provides a detailed exploration of this topic and sheds light on the reasons behind these claims.

This is why Big Pharma is advocating for the use of "Real World Evidence." In fact, companies like Pfizer have internally established a "Centre of Excellence" focused on Real World Data within their organizations. It is just another way to muddy the science and to shape their conversations.

🍍FDA unaware of Cardiac Arrest and death of a 7-year-old after vaccination!

Dr. Patrick Whelan, a UCLA pediatric rheumatologist and member of Harvard Medical School, made yet another mind-boggling revelation. He disclosed that he had filed an official report regarding the devastating case of a 7-year-old patient who suffered cardiac arrest and tragically passed away eight days later. Shockingly, Dr. Whelan did not receive any form of follow-up or response from the FDA regarding his report.

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It is important to consider that Dr. Whelan is one of the very few doctors who had the opportunity to meet with the FDA directly. This revelation is genuinely disturbing as it raises concerns about the possibility of numerous other doctors' reports being disregarded or overlooked similarly. In the pharmaceutical industry, I was trained to report any Serious Adverse Events within 24 hours because they were meant to be taken incredibly seriously, particularly when a person dies after taking medication. However, in this instance, we simply hear an FDA official brushing it off by stating, "email me the details!"

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🍍Megyn Kelly makes a U-Turn

In a separate news, Megyn Kelly, one of the most popular news anchors in America expresses regret taking the vaccine after she developed auto-immune disease for the first time in her life.

Here’s a tweet from April 2021 when she advocated taking the vaccine.

Here is a recent clip from September 2023 where she expressed regret. [SOURCE]

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I regret getting the vaccine….I don’t think I needed it, I think I would have been fine. I’d got COVID many times, and I … it was well past when the vaccine was doing what it was supposed to be doing. And then, for the first time, I tested positive for an autoimmune issue at my annual physical, and I went to the best rheumatologist in New York, and I asked her,
“Do you think this could have to do with the fact that I got
the DAMN booster and then got COVID within three weeks?”

AND SHE SAID YES!

Megyn Kelly, Sep 2023

Anyhoo, signing off for now!
A17