The FDA Has Lost Its Soul
David Gortler

While uncertainty occurs in every generation and with new policies, certain fundamental principles associated with our federal government’s independent agencies should always remain the same. Public-health decisions, for one, should be made based on evidence and data, not catering to the political whims of whomever is in office.

Unfortunately, D.C. partisan politics are alive and well at the Food and Drug Administration (FDA). The “woke” politics of the Democratic Party have taken over the FDA. It doesn’t help that the FDA is physically located just a few miles away from the Washington, D.C., “swamp.” That inevitably has led to an infestation of the politik liberale in what historically was and should always be a 100-percent non-partisan, science-based, data-driven agency.

Below, I summarize FDA policies and actions (and complacency) over the past two years that ignore an abundance of published, peer-reviewed, hard scientific evidence.

(See link for article)

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**Comment**

Gortler, PharmD, was four years into teaching pharmacology at Yale School of Medicine (YSM) when he was first approached by the U.S. Food and Drug Administration (FDA).  It wasn’t long before he was on the FDA’s staff as a medical officer evaluating new drugs for approval.  He recently completed a 2nd tour in the leadership team and served as an expert in drug safety, regulatory affairs and science policy.  He also was a part of the team that identified essential medicine, medical countermeasures, and critical inputs to serve patient needs in the event of another public health emergency.  He also conceptualized and helped found Valisure, the world’s first analytical pharmacy to ensure that global drugs are labeled accurately with regard to strength and without toxic adulteration.  Source

In other words, Gortler is speaking about the FDA as an insider who understands first-hand the problems within.

SUMMARY:

  • FDA has a revolving door with Big Pharma
    • Patrizia Cavazzoni, FDA Center for Drug and Evaluation and Research director, used to be a Pfizer exec and has approved many Alzheimer’s drugs that clearly don’t work.
    • Biden’s current FDA chief, Dr. Robert Califf, was FDA commissioner during the last year of the Obama administration who has made millions as a consultant for more than a dozen pharmaceutical corporations and holds millions more in pharmaceutical investments (at least 8 million). He was also involved in FDA’s mishandling of the opioid crisis.
      • Please note the quote from an internal FDA document:  “The action by the FDA…has created enormous opportunities” to expand the market. The drug company’s ads soon extolled the virtues of Oxycontin’s effectiveness and sales tripled.
    • Nine out of the last 10 FDA commissioners went on to work for Big Pharma or serve on a prescription drug company’s board of directors.
  • FDA has implemented a debased scientific standard for efficacy or safety of drug approvals catering to Biden’s ideologies.
  • FDA employees routinely zig-zag between Big Pharma and the FDA in order to obtain promotions.
  • FDA is silent as White House pays Pfizer $10.6 Billion for an ineffective COVID drug (paxlovid) based on a pilot study.  This drug cases a rebound effect & interacts with 32 classes of drugs.  (Image this happening in Lymeland!)
  • FDA ignores COVID injection safety & has done nothing to update labeling or warn the public.
    • 28,000 deaths have been reported to VAERS
    • 230,000 serious injuries
    • myocarditis and pericarditis are clear adverse events that are occurring
    • Cerebral venous thrombosis (CVT) is significantly associated with the shots
    • the shots don’t prevent infection or stop transmission
    • The FDA is silent on recent publications showing the potential for the shots to cause disease re-occurrence by reactivating otherwise latent conditions in one’s immune system.
    • FDA pushes shots for infants and kids based on limited efficacy and well-known risks.
    • FDA is basing booster decisions on a very small study that had a very low bar for effectiveness.
  • FDA ignores natural immunity
  • FDA is not transparent
  • FDA Commissioner Dr. Robert Califf spreads misinformation
  • FDA mocked those who use ivermectin and called it a horse dewormer:
  • In contrast to decades of safe usage of ivermectin and HCQ, the FDA is silent on dangerous puberty blockers and cross-sex hormones that alter children permanently and may cause infertility.  Rachel Levine, the transgender assistant secretary for health at HHS, publically promoted, without evidence of their safety, off-label use of “gender transitioning” drugs for children.
  • The FDA continued to keep baby-formula manufacturer Abbott shut down despite an investigation finding no evidence of their formulas causing infections in infants. The Biden admin purchased formulas from other countries where it is unknown if FDA inspections have ever even occurred, and continues to distribute this formula without performing any type of safety testing. In the meantime, the shortage has resulted in countless hospital admissions of starving infants.
  • The FDA’s silence, inaction, and decisions has contributed to the “Golden Age of Public Health Stupidity,” and under Biden every bad decision by the FDA has been “addressed with spin, closed ranks, finger-pointing, excuses, obfuscation, witholding of documents, and accusing critics of race-based motives.”
  • Gortler, once proud to work for the FDA, doesn’t even recognize it today. He states it’s become nothing more than “partisan shills and bullies seeking only to enrich themselves while selectively ignoring public health and hard scientific findings for the purpose of blindly serving the Biden White House. In turn, they relegate Americans to a terrifying, science-defying agenda.”
  • The FDA has not been held accountable for their actions, and democrats recently voted to give FDA employees a collective $28 million salary raise.
  • Gortler predicts only more partisan, unjustifiable decision-making under the Biden White House.