The FDA Bids Adieu to Science

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The FDA bids Adieu to Science

by Dr. 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 whoever is in office.  

Unfortunately, DC partisan politics are alive and well at the Food and Drug Administration (FDA).  “Woke” politics of the democratic party and have consolidated and taken over the FDA.  It doesn’t help that the FDA is on the outside of the Washington, DC “swamp.”  That inevitably has led to an infestation of the politik liberale in what historically was and should always be a 100% 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.  

FDA Personnel’s Revolving Door with Big Pharma

Specific FDA senior leadership, such as the new FDA Center for Drug Evaluation and Research director and ex-Pfizer executive Patrizia Cavazzoni, who was magically “leap-frog” promoted to her Senior Executive position at the FDA to replace Janet Woodcock, recently approved multiple Alzheimer’s drugs which clearly don’t work.  In addition, other FDA leadership has implemented a debased scientific standard for efficacy or safety of drug approvals in the name of catering to Biden’s ideologies which seemed to serve no other purpose other than to benefit Big Pharma, and at the expense and detriment of American taxpayers.  

Cavazzoni is not alone; FDA employees routinely zig-zag between Big Pharma and the FDA in order to obtain promotions and avoid making draconian-Big Pharma decisions, even when they painfully clear in order to protect their future fatter paycheck when they chose to leave the FDA.  

FDA silent as White House Prematurely Pays Pfizer 10.6 Billion for an Ineffective COVID-19 Drug, Based on a Pilot Study

Back in November 2021, the White House paid drugmaker Pfizer nearly $5.3 billion for 10 million treatment courses of its experimental COVID-19 treatment.  Paxlovid is an antiviral combination of nirmatrelvir and ritonavir.  In addition to the $5.3 billion already committed, in January, the U.S. announced a confidential additional “commitment” to order an additional 10 million doses (at the tune of an additional $5.3 billion, for a total of $10.6 billion).  In December 2021, Pfizer claimed initial study findings showing that Paxlovid cut the risk of hospitalization and death by nearly 90% in people with mild to moderate coronavirus infections.

Later, According to Pfizer’s official June 14, 2022, press release, results from Phase 2/3 of the amended Paxlovid protocol study showed that the drug was a failure, causing Pfizer to terminate its study early.  Cavazzoni would have had to permit the last min protocol change, but neither Pfizer nor the FDA made any public mention of it, leaving taxpayers to foot the bill for this ineffective drug.  

FDA’s Dead Silence on COVID-19 Vaccine Safety

The FDA seems to be ignoring serious safety concerns related to the COVID-19 vaccine.  There are no less than 1,291 different adverse events in almost 850,000 Americans alone.  Since immunization commencement, worldwide there have been over 28,000 deaths, and 230,000 serious injuries verified to have been directly associated with vaccine administration.  Fairly well-known, myocarditis and pericarditis are clear adverse events associated with mRNA COVID vaccine administration which can easily be diagnosed with echocardiograms and can sometimes be treated by inexpensive pharmacology and bed rest.  But for that to happen, clinicians must be warned.  

More recently, the blood-clotting condition cerebral venous thrombosis (CVT), which can cause serious neurological incapacitations, was found to be significantly associated with mRNA Covid vaccination, according to a major study in published in the medical journal Vaccines 

The FDA (along with Pfizer and Moderna) have done absolutely zero to update official labeling or otherwise warn or otherwise inform Americans of established risks. Indeed, the FDA’s homepage is still actively promoting Covid-19 vaccines and boosters, even though they do not seem to do little to nothing to prevent infections or transmission from existing mutations of COVID-19, including “long haul” COVID.  As a drug epidemiology expert, it is incumbent on the FDA to balance its promotion of vaccines with informing of the risks.

David_Gortler_EPPC_FDA_COVID19_Vaccine_Safety_Circular_Logic

The FDA has failed to comment on very recent publications which have detailed the more serious potential for existing mRNA vaccines to cause disease reoccurrence by re-activating otherwise latent conditions in one’s immune system. While still a hypothesis, the reasoning in the articles is sound and worthy of further examination by our erstwhile “non-political” drug experts at the FDA.  

FDA Pushes COVID-19 Vaccines in Infants and Kids Based on Limited Efficacy and Well-Established Risks

In May of 2022, the FDA approved a booster dose of the Pfizer COVID-19 shot for children 5 through 11 years of age.  On top of that, in June 2022, America became the only country on the planet that allows and promotes COVID-19 mRNA vaccines for kids as young as six months old.  

Much like Cavazzoni’s Alzheimer’s disease approval, vaccines for infants contradict clear clinical findings as research shows that the shots provide no benefit to adults and can, in fact, cause serious adverse effects, including death.  To cater to the White House’s “boosters for everyone,” FDA is basing its decisions on a very small study that had a very low bar for effectiveness.  For more specifics on the shortcomings of boosters in children, see the following initial summary by Dr. David Wiseman.)  The low bar set by the FDA will likely be even lower in the real world because drug trials use an “enriched” (i.e., extremely healthy) population.

FDA Ignores Natural Immunity 

The FDA has remained silent on the White House’s mandates to vaccinate individuals who already have already acquired seropositive antigenic natural immunity from COVID-19 through a previous infection.  The concept of acquired natural immunity following infection was established half a century ago. In April 2022, Moderna confirmed the same with its own 30,000-person study.  The bottom line for almost all people: If you have had the COVID-19 virus, you do not need vaccines or boosters due to the rules of natural immunity.

FDA’s Lack of Transparency

The FDA refused to formally release vaccine safety findings and all other public health information surrounding mRNA decision-making. It even defended the lack of transparency in court. Secrecy on public health issues leads to a lack of trust by the public and opposition to future critical new initiatives.  

FDA Commissioner Spreads Misinformation  

FDA Commissioner Dr. Robert Califf attempted to misinform Americans about what the leading cause of death is in the United States, ironically spreading misinformation when he stated: “misinformation is now our leading cause of death” in the U.S  He was promptly corrected by a fellow liberal CNN reporter.  With a bachelor’s degree in journalism.  On live television when Califf had to admit that no studies existed which could verify his claim.  Yikes!  

The FDA also purveyed misinformation to oppose hydroxychloroquine and ivermectin, legitimate treatments for COVID-19.  FDA condescendingly mocked Americans and physicians who had prescribed it simply because it was a recommendation made under President Trump’s administration.  The FDA even dedicated an official webpage, implying they are only used for animal deworming: “You are not a horse. You are not a cow. Seriously, y’all.  Stop it” they said.

“Transgenderism”

In contrast to ivermectin and hydroxychloroquine, the FDA has been silent as the grave regarding the administration of puberty-blockers and cross-sex hormones opposing the natural function of a 13-year-old-child’s own natural pituitary function and that unauthorized and FDA “off label” administration may render children permanently altered and infertile.  How about an FDA webpage stating: “You are not a female, you are a male.  Seriously, y’all . . . Stop it

The FDA again was again silent as Rachel Levine, the transgender Assistant Secretary for Health, evidence-less-ly and publically promoted off-label “gender transitioning” FDA drug use in children, outrageously declaring:  “there is no argument among medical professionals . . . about the value and the importance of gender-affirming care.”  Obviously, a comprehensive, evidence-based, academic debate on using dangerous chemicals to modify one’s gender would very clearly show how absurd of an idea this is, but not even one of the FDA’s ~20,000 employees could be bothered to speak out.  

The FDA also remained conspicuously silent as the Department of Health and Human Services’ Office of Population Affairs went on to circumvent the entire FDA and issued a standard of care “guidance document” called “Gender Affirming Care in Young Peopleraising many unanswered questions due to the lack of scientific basis supporting it.  

FDA-Caused Baby Formula Shortage

The FDA falsely accused Abbott’s baby formula manufacturing plant of causing infection in infants.  In a long series of eleven different tweets (which are worth reading), Abbott affirms that: “A comprehensive investigation by Abbott, FDA, and CDC found no evidence that our formulas caused infant illnesses.”  Still, the FDA kept Abbott shut down even after they found no infected formula.  After pointing fingers at everyone but themselves, the Biden administration was forced to purchase formula from other countries where it is unknown if FDA inspections have ever even occurred due to lack of FDA transparency.  Along the same lines, the White House continues to is distributing this formula to America’s infants without performing any kind of safety testing, which has persisted since the very beginning of 2022 and continues to the publication date of this article.  In the meantime, the shortage has resulted in countless hospital admissions for starving infants.

The Golden Age of Public Heath Stupidity

In summation, the FDA’s indifference to evidence-based science and medicine has thrust us into what I call the “golden age” of public health stupidity, which the FDA has contributed to with more than its fair share via its silence, inaction, or scientifically indefensible decisions.  Of course, it is worth noting, that not all divisions or individuals at the FDA are making poor decisions, and not all employees in divisions who have made questionable decisions have agreed with unjustifiable decisions.  

Unfortunately, it has come to the point that I hardly recognize the FDA today — the agency I was twice proud to work for throughout my career.  Sadly, multiple major divisions of the FDA and its senior leadership team have 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.  

Under Biden, every single bad decision at the FDA has been addressed with spin, close ranks, point fingers, make excuses, obfuscate, withhold documents and accuse your accusers of race/base motives.  

Has anyone at the FDA been held accountable for their actions?  Answer=no.  In fact, the democrats unbelievably very recently voted to give FDA employees a $28 million salary raise!  

Even worse — this is nowhere near the end of the “stupidity.”  I predict many, many more partisan, unjustifiable decision-making under the Biden White House, as the FDA remains unaccountable, and pushes forward with its blitzkrieg against medical science and public health.  

~~~

Dr. David Gortler is a pharmacologist, pharmacist, and FDA and health care policy oversight fellow and FDA reform advocate at the Ethics and Public Policy Center think tank in Washington, DC. He was a professor of pharmacology and biotechnology at the Yale University School of Medicine, where he also served as a faculty appointee to the Yale University Bioethics Center.  While at Yale, he was recruited by the FDA and become a medical officer who was later appointed as senior advisor to the FDA commissioner for drug safety, FDA science policy, and FDA regulatory affairs.  He is an exiled columnist from Forbes, where he used to write on drug safety, healthcare politics, and FDA policy.

 


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The Prisoner
The Prisoner
7 days ago

This is an excellent article from a knowledgeable person who also has a great ethical intellect. It is a great overall summary.

I wish you could comment on the “resignations” or removals of key people in the FDA panel and also the executive board. That happened in 2 periods in 2021.

The use of puberty blockers for “transitioning” being an off-label use is an important thing I did not know.

I think the FDA has a very checkered past on science but the current events are worse.

Last edited 7 days ago by The Prisoner
GuvGeek
GuvGeek
7 days ago

The first thing is that the Federal Government shouldn’t be allowed anywhere near “Public Health Policy”. The Federal Government is totally out of control and must be reduced to less than 5% of GDP.

Big Government does the bidding of the Rich, not of the People!