What's Going on With FDA Commissioner Marty Makary?

Pushing back on "new" Health Information Exchange...

FDA Commissioner Dr. Marty Makary has announced a significant policy shift in the agency's approach to vaccine safety monitoring. Moving away from the longstanding Vaccine Adverse Event Reporting System (VAERS), the FDA plans to utilize Health Information Exchanges (HIEs) to access real-world complication data through electronic health records (EHRs).

This transition aims to address concerns about the limitations of VAERS, which relies on self-reported data that can be incomplete or unverified. By leveraging EHRs, the FDA seeks to obtain more comprehensive and timely information on vaccine-related adverse events, enhancing the agency's ability to detect and respond to potential safety issues.

The proposed overhaul reflects a broader initiative to modernize the FDA's surveillance systems, ensuring they are equipped to handle the complexities of contemporary healthcare data. This move is seen as a material change in policy, emphasizing the FDA's commitment to utilizing advanced data analytics for public health decision-making reports HealthInsider Policy.

TrialSite suggests this approach can open up new insights into vaccine safety.

Accessing Electronic Health Records (EHRs) through Health Information Exchanges (HIEs) offers significant advantages over the passive Vaccine Adverse Event Reporting System (VAERS) in vaccine safety surveillance. Here's why:

1. Active vs. Passive Surveillance

• VAERS is passive: It relies on voluntary reports from patients, providers, or manufacturers. Many adverse events go unreported—some estimates suggest up to 90% underreporting.

• EHR-based systems are active: Data is automatically collected in real time during routine care, offering a far broader and more representative picture of outcomes.

2. Comprehensive, Longitudinal Data

• EHRs contain full patient histories—medications, lab results, comorbidities, diagnoses, and outcomes. This enables more nuanced understanding of whether a vaccine may plausibly be linked to a health event.

• VAERS entries often lack critical context or are incomplete, making causality hard to assess.

3. Real-Time Detection

• EHR access enables near real-time analysis of trends across millions of patient records. Adverse events can be flagged quickly based on symptom patterns or temporal associations.

• VAERS reports may take weeks or months to be filed, reviewed, and analyzed.

4. Reduced Bias and Noise

• VAERS is prone to reporting bias, including both overreporting (due to media attention) and underreporting (due to lack of awareness or burden).

• EHR-based systems capture all events, whether or not someone suspects a vaccine connection, reducing both bias and false signals.

5. Improved Signal Validation

• Algorithms can automatically compare vaccinated vs. unvaccinated cohorts within EHR datasets to detect excess risk and adjust for confounding factors—something VAERS cannot do without external data linkage.

Bottom Line

Dr. Makary’s plan to use EHRs marks a shift toward proactive, data-rich, and population-scale safety monitoring. If implemented rigorously—with transparency, proper oversight, and access to anonymized national HIE networks—it could dramatically improve the FDA’s ability to detect rare but serious vaccine-related complications that VAERS may miss or mischaracterize.

Original TrialSite source: https://www.trialsitenews.com/a/fda-proposes-shift-from-vaers-to-ehr-based-vaccine-safety-monitoringbig-advancement-for-safety-movement-505ece82

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WelcomeTheEagle’s Bottom Line

Makary is discounting VAERS. VAERS on paper as it was designed CAN be a great system! The “red flag signals” are there even with obfuscated and manipulated data because the elephant in the room is to big to hide! Give me a break Makary. Same pig different lipstick. Don’t gloss over the malfeasance and data manipulation going on within the halls of CDC/FDA from bribed and pimped out employees and Directors. Even Bobby knows VAERS does not publish ALL legitimate reports received!

If you were sent to head FDA to fight the pharma cabal, then grow a nut sack and do the job you were sent to do. If you were sent to be the next hood ornament and do the Big Pharma song and dance, then we are on to you! God Bless

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Conclusion:

I’m not saying VAERS doesn’t need a lot of improvements even it was being managed honestly. What I’m saying is Makary seems to be putting on his ballerina shoes and performing the next choreographed Big Pharma song and dance? Don’t hate the game, hate the players

If this article makes it to Marty, then check out the some of the quick death (under 3hrs): https://www.vaersaware.com/3-hour-deaths

The hidden dead kids:

https://www.vaersaware.com/kids-unk-age-deaths

The VAERS Throttling (Purposeful delay of publication):

https://www.vaersaware.com/throttled-deaths

You are trying to hypnotize people with words like “Bias Risk”, “Detection Power”, “Real Time Detection” and the rest of the mumbo jumbo, these shots should have and could have been pulled long ago but nobody had the nut sack to fight big pharma or stop accepting the bribes and perks.

God Bless and please, please support the Eagle!