Lived across the US, Europe & Caribbean. Experience in military, government, legal, engineering, organizational consulting. Student of history. Redeemed.
And I set my mind to know wisdom and to know madness and folly; I realized that this also is striving after wind. • Because in much wisdom there is much grief, and increasing knowledge results in increasing pain.
King Solomon, Ecclesiastes 1:17-18
🚨 NEW DOCUMENTS: NIH scientists charged with attempting to smuggle monkeypox into the United States had a years-long history of skirting rules for moving dangerous pathogens.
READ the documents: https://t.co/q0WfkjUA5a
FDA’s CBER is the center responsible for regulating vaccines, biologics, blood products, cellular therapy, and gene therapy products, including the very systems that determine whether vaccine injuries are detected, investigated, acknowledged, warned about, or ignored.
FDA’s current CBER leadership listing, the structure is alarming: the Acting Director is Karim Mikhail, a former pharmaceutical executive who spent more than two decades at Merck and later became President and CEO of Amarin Corporation, a biopharmaceutical company focused on cardiovascular disease. FDA now places him over CBER: the center that contains vaccine review, biologics quality, pharmacovigilance, compliance, and gene-therapy CMC.
This is not a harmless staffing chart. This is the architecture of abandonment.
The CBER Deputy Director position is vacant. The Office of Biostatistics and Pharmacovigilance Director position is vacant. The Office of Vaccines Research and Review Deputy Director position is vacant. The Office of Therapeutic Products Deputy Director position is vacant. The Office of Cellular Therapy and Human Tissue CMC Director position is vacant. The Office of Clinical Evaluation Deputy Director position is vacant. The Office of Pharmacology/Toxicology Director position is vacant. The Office of Plasma Protein Therapeutics CMC Deputy Director position is vacant.
For vaccine-injured Americans, this is catastrophic optics. The agency center responsible for evaluating biologics safety, vaccine harm, manufacturing quality, pharmacovigilance, and gene-therapy oversight is being led by a long-time pharma insider while key safety, scientific, clinical, pharmacology-toxicology, and oversight positions sit empty.
The Office of Biostatistics and Pharmacovigilance is not decorative. That is the office tied to safety-signal detection, adverse-event evaluation, benefit-risk analysis, and post-market surveillance. When the top seat in that office is vacant, injured people are left wondering who is accountable for connecting the dots, escalating signals, forcing label changes, demanding studies, or publicly admitting when harms were missed.
The Office of Vaccines Research and Review is also central. A vacant deputy position in the vaccine office matters because this is where scientific review, regulatory judgment, and institutional continuity are supposed to exist, especially during a historic vaccine-safety crisis.
The Office of Compliance and Biologics Quality matters because manufacturing quality is not a side issue. It is where questions about biologics quality, contamination, specifications, release criteria, and compliance should be taken seriously. You know... the entire reason these products are now under scrutiny for harming so many of us: contamination, manufacturing standards, release testing, and whether biologics quality controls were enough to protect the public.
The Office of Therapeutic Products and its gene-therapy structure may be one of the most important parts of the entire CBER chart. This is where FDA’s biologics and gene-therapy oversight lives. The very framework that should matter if mRNA products functioned as gene-therapy-like products, delivered genetic instructions, required strict CMC controls, raised biodistribution questions, carried residual DNA/RNA contamination concerns, or needed long-term follow-up.
And that structure is not solid. It is full of gaps.
That is what is wrong.
These vacancies hurt us.
They hurt us by slowing recognition of safety signals.
They hurt us by weakening accountability.
They hurt us by letting agencies blame “process” instead of people.
They hurt us by making it harder to know who is responsible.
They hurt us by allowing historic injury patterns to remain scattered across databases instead of being treated as a national emergency.
They hurt us by leaving the vaccine-injured trapped between denial, delay, and bureaucratic silence.
And they matter because legal cases cannot be built on emotion alone. It is built on the question of whether federal agencies and manufacturers represented these products honestly, classified them correctly, monitored them adequately, disclosed risks truthfully, and paid billions under contracts that may have rested on false or incomplete claims.
The issue is not simply whether people had “side effects.” The issue is whether the government paid billions for products that was misrepresented, misclassified, insufficiently tested, inadequately monitored, or manufactured under standards that would not survive real gene-therapy-level scrutiny.
A functioning gene-therapy oversight structure should be able to answer those questions.
A hollowed-out one can avoid them.
A hollowed-out CBER led by a former Merck and Amarin pharmaceutical executive does not make those questions go away.
It makes outside DOJ scrutiny more necessary.
The government cannot tell injured Americans to trust the system while the very offices responsible for vaccine safety, pharmacovigilance, biologics quality, pharmacology-toxicology, clinical evaluation, and gene-therapy oversight are vacant, acting, or unstable.
Do something NOW or your names will forever be enshrined in the history books as those who let tens of thousands suffer and die. Tick Tock. Midterms are upon us.
Pediatricians receive ZERO training on vaccine injuries. No questions on their board exams. No protocols for treatment. But they're trained extensively on how to overcome your "vaccine hesitancy." Let that sink in. @CHDTVLive@ChildrensHD@AutismActionNet
For the complete story @ The Defender:
https://t.co/693iIYUO9r
The relationship between Big Pharma and those who regulate them has been incestuous for decades. Indeed, with the entire medical community.
But they screwed up. They overreached with all the machinations of the Covid vaccine caper, and the extent of the lies, misdirection and consequences in lost and damaged lives- not to mention years of economic damage- became too difficult for any curious public to miss or for them to cover up (although they tried).
These are the facts. In my opinion, this makes it more important than a cadre of scientists or even a field of science. Combined with all the other pure medical fraud being unearthed (fake businesses but also fronted by MDs and other medical professionals) and the consequences from the population will not be pretty.
The vaccine business is "finding out". Right now.
Gentlemen's agreements and virtue won't work. The incentives for corruption are too high, and hard to police. There has to be a clear, hard line visible to the public that cannot be crossed.
Our nation's governance is at stake and may not survive another failure of this magnitude.
I can't remember the last time I had a risk vs reward conversation with a doc about a drug or procedure that I didn't have to initiate and pry out of them.
An aeronautical engineer and rescue helo pilot... I understand weighing risks, but found that few docs do. They memorized standard of care, so they're done.
How do you get "informed consent" out of that?
Well put.
I'm simpatico, for sure. If they don't keep selling me BS like the Food Pyramid, annual flu shots, every condition has a drug that will fix it (particularly mental conditions) and that they're "my daddy".
They are my paid partner in consulting for my best health outcomes. That's as in "partner"- we both bring experience and information needed to the table.
Unfortunately, too often I've found theirs is limited to what they were told in med school (30 years ago), heard at a comped conference or were told by a(n attractive) pharma rep.
That’s it. I'm easy to please.
During COVID Patients were told these “gene injections” were safe and effective.
That claim was made with a confidence that the available data at the time did not support. The trials were of insufficient duration to assess long-term safety. The populations studied did not fully represent those who would ultimately receive the product. The conditions of emergency authorisation, which exist precisely because the normal evidence threshold has not been met, were not communicated clearly to the people being asked to consent.
When individuals reported severe reactions, the appropriate medical response would have been documentation, investigation, and honest engagement with what the reports might indicate.
What many received instead was dismissal. The suggestion that their symptoms were unrelated, psychosomatic, or coincidental. The absence of diagnostic frameworks to even record what was happening to them. The closure of the door that informed consent requires to remain open, the door that says if something goes wrong, we will acknowledge it and investigate.
These are not inflammatory claims. They are the documented experience of a large number of people whose accounts are consistent across countries, across demographics, and across medical systems that had every institutional incentive to find another explanation.
Medicine rests on three foundations that were compromised during this period.
Transparency… about what was known, what was not known, and what the data actually showed rather than what the communications strategy required it to show.
Accountability… the willingness to examine adverse outcomes honestly and adjust course when the evidence demands it.
Informed consent… genuine, voluntary, uncoerced consent from people who have been given accurate information including the uncertainties.
These are not controversial principles. They are the ethical foundation of the profession.
The answers that were owed before the first dose was administered are still owed now. We still want them.
@bell00david It informs future policy and behavior of medical research criminals to protect the population... if prosecutions and punishments follow investigations.
I voted for this.
@JordanAbbottMD MDs overwhelmingly supported Covid policies that were corrupt and deadly. Of ALL citizens, THEY had the opportunity to research and KNOW the majority of the policies were BS.
That they let us down is an understatement.
Cry me a river.
FDA Allows Public Comments on Moderna's New mRNA Influenza 'Pandemic' Vaccine MFLUSIVA (mRNA-1010)
MFLUSIVA triggers six times more severe reactions for less than 1% absolute benefit, Moderna scientists admitted last month in the New England Journal of Medicine.
"We Shouldn't Let This Get Out." Alleged Internal Communications From the Agencies That Shaped COVID Policy.
Documents obtained through FOIA requests and whistleblower testimony have revealed internal communications where officials discussed suppressing safety signals, softening language in published reports, and coordinating messaging to protect vaccine uptake. These aren't allegations from fringe sources. They are subpoenaed communications, Senate testimony, and published FOIA documents. The people who said "we shouldn't let this get out" were in charge of public health. That is the crisis.
Join the Fight: https://t.co/rvCeXmwbdp
Courtesy of Savage Minds @SavageMindsMag, Julian Vigo @_JVigo
Listen to the Full Episode: https://t.co/EzT8dN70By
#MedicalFreedom
We must "slash" U.S. childhood vaccinations because most of them are not administered on a proper risk vs reward analysis and therefore lacks "informed consent" of the parent.
AND every vaccine on the schedule protects the manufacturer from liability for what and how they produced.
So, of course, THEY do everything they can to PREVENT a risk analysis, including bribe physicians.
The Tetanus shots are prime examples, but there are many others.
Need to keep reminding the Repub Senators that POSTING in support of the SAVE America Act is NOT FIGHTING for the bill.
They falsely claim to be Fighters - but they're just Virtue Signaling!