COVID-19
Florida Surgeon General’s Call to Halt Use of the Vaccines Sparks Debate
Dr Joseph Ladapo, Florida’s Surgeon General at the microphone
From the Brownstone Institute
On January 3, 2024, Florida Surgeon General Joseph Ladapo called for a halt in the use of the mRNA Covid-19 vaccines after US health agencies failed to adequately address his concerns about DNA contamination in the products.
In a statement on X, Ladapo accused the FDA and CDC of always playing it “fast and loose” with Covid-19 safety, but their failure to test whether DNA fragments in the vaccine could integrate into a person’s genome was “intolerable.”
As I and others have pointed out on numerous occasions, the FDA’s own guidance on regulatory limits for residual DNA in vaccines states “there are several potential mechanisms by which residual DNA could be oncogenic [cause cancer], including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.”
In a letter, Ladapo had also asked the two agencies if they’d carried out any risk assessment regarding the presence of the “SV40 promoter” in the vaccines, which is thought to enhance DNA integration into host cells.
But the FDA’s top vaccine official Peter Marks responded to Ladapo’s demand for answers with intransigence and obfuscation.
Similar to how the FDA shut down my previous enquiries into this matter, the agency failed to provide Ladapo with any evidence that it had even conducted tests to address the risk of genomic integration.
In fact, Marks had the temerity to imply that ongoing discussion about this topic was perpetuating misinformation “which results in vaccine hesitancy that lowers vaccine uptake.”
Ladapo explained;
DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA Covid-19 vaccine recipients. If the risks of DNA integration have not been assessed for mRNA Covid-19 vaccines, these vaccines are not appropriate for use in human beings.
He also recommended that providers concerned about health risks of Covid-19 should prioritise patient access to non-mRNA Covid-19 vaccines and treatment.
Quick to dismiss Ladapo’s concerns was Paul Offit, director of the Vaccine Education Centre at Children’s Hospital of Philadelphia, who serves on the FDA’s vaccine advisory committee.
Offit hit back in a video published on MedPage Today saying, “It is hard to believe that Dr Ladapo actually issued that statement…[DNA fragments] can’t possibly do harm. So scaring people unnecessarily like this has been hard to watch.”
Professor Paul Offit, Children’s Hospital of Philadelphia
Unfortunately, Offit’s video contains a series of erroneous statements that exposes his fundamental misunderstanding of the manufacturing and regulation of Covid vaccines.
For example, Offit says it’s unlikely that DNA fragments enter the cytoplasm of cells, or survive, once they’re inside.
“Our cytoplasm hates foreign DNA and it has a variety of mechanisms, including innate immunological mechanisms and enzymes, to destroy foreign DNA,” says Offit.
“That DNA, which would never survive the cytoplasm, would have to then cross the nuclear membrane into the nucleus, which would require a nuclear access signal that these DNA fragments don’t have…So the chance that DNA could affect your DNA is zero,” he adds.
But this statement is disingenuous on multiple fronts.
Offit talked about DNA fragments as if they were not encapsulated in lipid nanoparticles, which specifically ferry the genetic material into the cell cytoplasm. Indeed, without the lipid nanoparticles, the vaccines would never have made it to market.
A recent publication in Nature found that within hours, around 7% of cells are integrated when mixed with a transfection solution containing linear pieces of DNA.
Offit also said that DNA wouldn’t cross into the cell’s nucleus, but scientists have known that foreign DNA can be delivered into mammalian cells to modify a host cell’s genetic makeup in a process called “DNA transfection.”
It also ignores the fact that the DNA fragments contain the “SV40 promoter” which includes a nuclear targeting signal (NTS) to aid its entry into the nucleus.
A full critique of Offit’s commentary was recently published by Dr Robert Malone who pioneered some of the early work into mRNA technology.
Phillip Buckhaults, a cancer genomics expert, and professor at the University of South Carolina, has confirmed the presence of DNA fragments in the vaccines after replicating the work of McKernan et al.
Buckhaults has welcomed Ladapo’s announcement.
“I’m glad Dr Ladapo is taking a firm leadership stance to protect the people under his care. I think he is taking a lot of heat over genuinely looking out for others. I think he is acting in good faith and that is to be respected,” says Buckhaults.
Professor Phillip Buckhaults, University of South Carolina
He also believes that Ladapo’s stance on the mRNA vaccines is “based on solid scientific reasoning” because the long-term genomic safety has not been demonstrated for fragments of DNA that are encapsulated in lipid nanoparticles.
However, rather than completely halting the vaccines, Buckhaults says he would err on the side of caution and still “recommend the vaccine to select populations who are at high risk for death from [Covid-19].”
Buckhaults hopes that Ladapo can use his authority to compel the FDA to request an extra “cheap and easy step” in the processing of the vaccines to remove the vast majority of DNA from upcoming batches.
“Then we would not even need to have this argument about DNA anymore. The risk of the DNA would be essentially gone and the crisis in confidence in leadership would be addressed,” he says.
Buckhaults has testified before a South Carolina Senate hearing about his alarm over the “very real hazard” that these fragments of foreign DNA can insert themselves into a person’s genome and become a “permanent fixture of the cell.”
He has also discussed with me at length the potential harms to people’s health caused by DNA contamination in the mRNA vaccines. Last year, Buckhaults notified the FDA of his concerns via email but never received a response.
Supplementary information: reading:
FDA shuts down enquiries about DNA contamination in [Covid] vaccines
EXCLUSIVE: An interview with Buckhaults about DNA contamination in [Covid] vaccines
Republished from the author’s Substack
Author
From the Brownstone Institute
In the wake of the FDA settling a lawsuit brought against it for wantonly and aggressively smearing ivermectin, the agency has deleted its postings. That’s good, but we shouldn’t forget how egregiously it mischaracterized the drug, ignored copious evidence in its favor, and portrayed its proponents as dangerous crackpots.
About 30 months ago, America’s FDA was publishing articles with headlines like this: “Should I take ivermectin to treat COVID?” Answer: No. The agency also told Americans not to use ivermectin to prevent Covid. Then, in what became known as its infamous “horse tweet,” the FDA even patronizingly told Americans: “Seriously, y’all. stop it.”
Prescribers who advocated for alternate treatments like ivermectin or hydroxychloroquine were mocked online by America’s “trusted journalists” as being part of a “right-wing conspiracy” and labeled “hucksters.” Those who didn’t demure to the Covid mRNA or other Big Pharma treatment narratives were banned, fired, and spoken harshly about around the world and into the reaches of the stratosphere in what seemed like coordinated messaging.
Many clinicians lost their jobs – at best. At worst, their reputations, practices, finances, and careers were shattered. If that was not bad enough, after losing their jobs, state medical and pharmacy boards initiated legal proceedings against their licensure, singling out their “off-label” Covid treatments, despite other off-label treatments being a near-ubiquitous component of pharmacy and medical practice.
Within days of FDA’s initial postings above, the American Pharmacist’s Association (APhA) the American Society of Health System Pharmacists (ASHP), and the American Medical Association (AMA) all collaborated to release a joint press release condemning doctors who prescribed ivermectin to treat Covid, but it appears that these organizations, instead of actually performing independent analysis of primary literature data, blindly regurgitated FDA, CDC, and NIH plus other government and Big Pharma talking points “strongly opposing” ivermectin use.
For generations and especially during the Covid pandemic, professionals depended on these “elite” medical groups. Some of them have existed for around 170 years and have around $150 million to $1.2 billion in assets, so they clearly had the history, personnel, and wherewithal to objectively examine published data. Even beyond that, the AMA has several floors in a skyscraper in Chicago and the APhA’s Constitution Avenue’s “landmark headquarters” is so luxuriant that it is advertised and utilized as a wedding venue.
Of course, that extravagance was paid for by millions of pharmacists, physicians, and benefactors who expected these organizations to act as a checksum and ensure excellent clinical practice standards. These medical organizations have a duty to honor their histories, responsibilities, and ethical duties to better the human condition through verified scientific evidence. Instead, they appeared to outrageously abandon their obligations from their lofty positions of respect, comfort, money, and power.
APhA, ASHP, and AMA Clinical Declarations Now Indefensible:
On March 22, the FDA rightly acquiesced and agreed to remove their anti-ivermectin postings due to 1) a lawsuit filed against them and 2) the impossible task of having to defend themselves with an overwhelming amount of data disagreeing with not only dispensing medical recommendations, but the published data backing their Covid-19 use (e.g., see below).
With that gone, the APhA, ASHP, and AMA assertions suddenly have no leg upon which to stand.
Several non-FDA links within their press releases have (unsurprisingly) also quietly vanished with no explanation. NIH references are slated to be shut down, on top of multiple FDA and CDC links already no longer working.
Ivermectin Mechanism of Action, History and Evidence:
The broad antiviral mechanism of action of ivermectin is complicated and may partially involve blocking the uptake of viral proteins, but the bottom line is that it has been shown to yield positive results in a variety of published results for Covid-19. Had APhA, ASHP, and AMA pharmacists and physicians independently examined the data, (as I, just one drug-safety analyst without fancy headquarters, have done) rather than simply parroting now-deleted narratives of others, they would have learned that ivermectin works as an antiviral.
It has an extensively proven track record of being not just safe – but astonishingly safe for a variety of viral diseases. This is not breaking or fringe science; it has been known for years. Ivermectin is such a safe and effective drug that back in 2015 it was the first drug for infectious disease associated with a Nobel Prize in 60 years.
While I have stacks of electronic files and printed materials, dog-eared and food/drink-stained, there is a most elegantly presented meta-analysis website designed by some brainy and web-savvy scientists detailing over 100 studies from over 1,000 different scientists, involving over 140,000 patients in 29 countries describing the benefit and safety of ivermectin for Covid-19 treatment. It actually appears to be more extensive than Cochrane’s outdated review of ivermectin which only examined 14 trials – and excluded seven of them from consideration.
According to these data, consisting of smaller international publications that include real-world findings and small observational studies, ivermectin shows a statistically significant lower Covid-19 risk as detailed in the image above.
The less-positive findings associated with late treatment/viral clearance/hospitalization data cohort were associated with delayed administration. That is because any late-state use of antiviral pharmacology tends to be ineffective after hundreds of millions of viral replications have taken place – whether it’s cold sores, influenza, AIDS, or Covid-19.
ASHP, APhA, and AMA Press Releases Contradict Available Data and Clinical Practice Standards:
When the FDA scolded Americans not to use ivermectin for Covid-19, on April 25, 2021, there were 43 different published manuscripts showing its potential benefit. Around three months later, on August 21, the FDA released its infamous horse/cow tweet which implied that ivermectin was only for animals, not humans. This “doubling down” occurred as an additional 20 studies had subsequently been written detailing additional benefits for Covid-19. See the timeline below:
Multiple APhA/ASHP/AMA statements ignored published scientific and clinical evidence. Specifically, statements declaring the: “Use of ivermectin for the prevention and treatment of COVID-19 has been demonstrated to be harmful to patients” (bold emphasis theirs) are objectively inaccurate. I do not know on what basis those statements were made. The recommendation to healthcare professionals to “…counsel patients against use of ivermectin as a treatment for COVID-19, including emphasizing the potentially toxic effects of this drug” represents a departure from pharmacist and physician practice standards.
The absurdity of the latter statement is quite outrageous. Pharmacists and physicians know that all drugs have “…potentially toxic effects” so if they applied the standard of “emphasizing potentially toxic effects” while discussing every prescribed medication, few if any patients would ever take any of their medications. The APhA/ASHP/AMA discriminatory hostility towards ivermectin was not only clinically unjustified and irresponsible; it was – as far as I know – without precedent.
These anti-ivermectin talking points also benefited new Big Pharma product advancement including the rebounding, overpriced taxpayer-funded boondoggle of Paxlovid and Remdesivir, such a “safe and effective” drug that hospitals had to be heavily incentivized (i.e., bribed) to entice nurses, physicians, and hospital administrators to promote its use with a staggering 20% “bonus” on the entire hospital bill paid by our federal government. Remdesivir quickly earned the sardonic nickname of “run-death-is-near” by American Frontline Nurses and others, due to serious questions about its clinical benefit.
Why were federal agencies’ and professional organizations’ talking points against ivermectin not backed by independent, original APhA/ASHP/AMA data examinations? That question needs to be thoroughly probed with regard to potential regulatory capture within these groups.
Both then and now, those FDA webpages, postings, and tweets were not just biased. They were irresponsible in their denigrating ivermectin as an off-label treatment, which is why they are now gone.
The question is, who was worse? The FDA for overstepping its congressional authority in not just making medical recommendations, but making recommendations ignoring data, or the servile “independent” elite professional organizations exuberantly echoing a narrative?
Prescient or not, here is an excerpt of the expert panel congressional testimony to the Covid Select House Oversight Committee, explaining the FDA’s disparaging ivermectin versus promoting mRNA injections using an automobile analogy, delivered just one day prior to the FDA’s yielding to physicians’ lawsuit to remove its postings denigrating ivermectin:
Despite FDA Settlement and Data Abundance, the Press is Still Anti-Ivermectin
Even after the FDA’s about-face, on March 26, 2024, a Los Angeles Times journalist published a column calling the removal of FDA tweets “groundless” unilaterally declaring ivermectin is still “conclusively shown to be useless against COVID-19,” comparing ivermectin to “snake oil,” and describing those who advocate for it as “purveyors of useless but lucrative nostrums” …whatever that means. (Regarding the ‘lucrative’ claim, it is worth noting that since ivermectin is generic and inexpensively available, it is not ‘lucrative’ to anyone.) It also referenced ivermectin lacking “scientific validation,” even though the above-cited data abundantly indicates otherwise.
Regarding the FDA’s choice to settle its lawsuit disparaging ivermectin, the FDA’s Center for Drug Evaluation and Research leadership isn’t “shooting itself in the foot” as the Times says. It seems that the FDA is indirectly attempting to prevent further embarrassment likely because it now realizes that its ivermectin assertions were wrong and outdated with every passing day. But where does that leave the APhA, ASHP, or AMA who heavily relied on these now deleted FDA links in their press releases?
The APhA, ASHP, AMA Response to the FDA’s Removal of Postings Used in Press Releases? An Embarrassing Silence:
Over a month later, and as of this publication date, none of these organizations have a single thing to say about their previous press releases quoting the now-removed FDA articles and tweets. In fact, here is an indication of their concerns: one week after the FDA acquiesced to remove its postings in ivermectin, APhA’s newly elected speaker chair and pharmacist Mary Klein is “happy danc[ing]” and giving her official acceptance speech wearing Mickey Mouse ears. ASHP’s (A/K/A “#MedicationExperts”) still shows its official page with clinicians wearing ineffective, unnecessary surgical masks despite the pandemic having ended well over a year ago and Cochrane reviews indicating that this sort of masking is almost certainly ineffective. AMA officials are making multiple posts on transgender issues and declaring climate change a public health crisis, – all while fully ignoring its impactful, incorrect, inappropriate statements on ivermectin.
Take a look:
The APhA, ASHP, and AMA have remained conspicuously silent on this topic while focusing their newsfeeds on everything but. To this day, their press releases remain online, with multiple dead links to government agencies. In blindly backing incorrect narratives pointing to removed web pages, they are now all alone in their ivermectin declarations.
Bottom line: ivermectin was and is safe, and more than likely effective for Covid when timed and dosed correctly, and under medical supervision, despite what was declared by organizations and federal officials. In fact, ivermectin’s general antiviral activity might even be helpful for bird flu (avian influenza) in animals and humans, in lieu of another novel adverse-event-ridden “warp speed” mRNA “vaccine” with an endless boondoggle of boosters.
The past and current record on ivermectin needs to be set straight. We know there is an important (but untransparent) list of who is responsible for misrepresenting published data, but will anyone be held accountable?
DISCLAIMER: Do NOT discontinue or initiate taking ANY drug without first discussing it with a pharmacist or physician you know and trust.
Author
COVID-19
NIH Quietly Altered Definition For Gain-Of-Function Research On Its Website, Former Fauci Aide Confirms
From the Daily Caller News Foundation
By JASON COHEN
National Institutes of Health (NIH) Principal Deputy Director Lawrence Tabak confirmed on Thursday that his agency’s communications department altered NIH’s definition for gain-of-function research, with the change being “vetted” by “experts.”
The NIH until Oct. 20, 2021 defined this research as “modif[ying] a biological agent so that it confers new or enhanced activity to that agent,” while “some scientists use the term broadly to refer to any such modification,” according to the House Oversight Committee. Republican Rep. Nicole Malliotakis of New York questioned Tabak, a former aide to Dr. Anthony Fauci, about the agency changing its definition of the research on its website, asking him who authorized the alteration.
WATCH:
The current website does not define gain-of-function research, but asserts this research is usually uninvolved with enhanced potential pandemic pathogens.
“The change was made by our communications department because of the confusion that people have about the generic term of gain-of-function and the specific term gain-of-function,” Tabak testified.
Malliotakis responded by suggesting the communications department would not be qualified to make a change like this and must have had other input.
“The content was vetted,” Tabak testified. “By individuals who are subject-matter experts.”
Fauci firmly denied that the National Institute of Allergy and Infectious Diseases (NIAID) funded gain-of-function research on bat-based coronaviruses at the Wuhan Institute of Virology (WIV) before the COVID-19 pandemic during a Senate hearing in May 2021.
“The NIH has not ever and does not now fund gain of function research in the Wuhan Institute of Virology,” Fauci said.
Tabak testified on Thursday that the NIH did fund this research at the Wuhan Institute of Virology, but it “depends on [the] definition.”
The NIAID, which Fauci previously led, funded the nonprofit group EcoHealth Alliance to study bat-based coronaviruses in China that consisted of the transfer of $600,000 to the WIV, the Daily Caller News Foundation previously reported.
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