Tuesday, January 16, 2024
DNA Contaminants in COVID Vaccines Are ‘Beyond the Pale’: Florida Surgeon General Explains the Call for Vaccine Halt
On Jan. 3, the office of Florida Surgeon General Dr. Joseph Ladapo issued a statement calling for the halt in the use of COVID-19 mRNA vaccines, citing the recent discovery of DNA contaminants in the vaccine vials.
On the Jan. 12 episode of EpochTV’s “American Thought Leaders,“ Dr. Ladapo explained why he called for a halt, saying that while there are also safety concerns with the COVID mRNA vaccines linking them to a multitude of adverse events, the recent discovery is ”beyond the pale.”
“DNA is a common contaminant of many biological products,” he told the show’s host, Jan Jekielek. “We can use DNA to produce different drugs like insulin, other biologics—and that’s a wonderful innovation, and normally, that DNA doesn’t pose a problem.”
Human cells are resistant to DNA entry, and this prevents harming the integrity of the cell’s DNA.
However, since the mRNA vaccines use lipid nanoparticles, which deliver mRNA into the cells directly, DNA contaminants could also be able to enter the cells. Some scientists, like Dr. Ladapo, are concerned that the DNA from the vaccine may integrate with the human genome.
Prominent officials at the U.S. Food and Drug Administration (FDA) disagree.
On Dec. 6, Dr. Ladapo sent a letter to FDA commissioner Dr. Robert Califf and the U.S. Centers for Disease Control and Prevention (CDC) director, Dr. Mandy Cohen. In his letter, he asked if there have been risk assessments of the vaccine DNA integrating into human DNA, especially regarding the controversial SV40 promoter/enhancer region found in Pfizer’s vaccine.
Other questions included whether risk assessments have been done on DNA integration in reproductive cells and if the current levels of DNA residuals are acceptable under the FDA’s standards.
“We’ve gotten ... lengthy responses that don’t answer the question,” Dr. Ladapo said.
In his response, Dr. Marks wrote that DNA integration “is quite implausible,” adding that animal studies show “no evidence indicative for genotoxicity.”
No tests were mentioned that would assess if DNA integration is occurring.
Dr. Ladapo believes it would be reckless not to test for DNA integration, a potential risk once DNA enters the cell.
“Their position is, oh, no, it’s fine. Everything’s fine; safe and effective. That’s not only not good enough, but it’s completely unacceptable,” Dr. Ladapo said. “And that’s why I made that determination, and it’s absolutely the correct call.”
DNA Contamination: The SV40 Promoter Controversy
Both Moderna and Pfizer mRNA vaccines contain DNA contaminants, but only the Pfizer vaccines have also been found to contain SV40 promoter/enhancer DNA, which has since become a topic of debate.
SV40, or simian vacuolating virus 40, is a DNA virus that sometimes causes cancer in animals.
However, the SV40 promoter/enhancer found in the vaccines is only a tiny section of the DNA; it is not equivalent to the entire SV40 virus or its protein.
Promoter-enhancers are sections of DNA that can control the activity of other DNA.
“With DNA, there are different regions that tell other parts of DNA whether to be active or not,” Dr. Ladapo said. “This type of control process is very important ... The absence of control can, for example, lead to cancer ... [and] other metabolic abnormalities.”
In his letter to the FDA, Dr. Ladapo asked about the additional risk of the SV40 promoter/enhancer region’s DNA integration.
Dr. Marks answered that there were no genes for SV40 proteins nor SV40 proteins themselves present in the vaccine.
But Dr. Ladapo believes Dr. Marks is intentionally not answering the question. “No one’s talking about SV40 protein ... we talked about the promoter/enhancer region. They have to be doing it intentionally,” Dr. Ladapo said.
The Risks of DNA Integration
It is currently unknown whether DNA introduced into the body is being integrated into the cell’s human genome; and if it’s integrated, what impact will it have.
Only around 1 percent of the human DNA produces protein; the job of the other 99 percent of DNA is mostly unknown.
“There’s ... a lot of uncertainty about our genome—what it does, how it supports life and creates life, and creates the miracle of each individual human being,” Dr. Ladapo said. “What we do understand is that some of the potential risks of DNA integration include development of cancers, because ... of the regulation of different aspects of DNA and cell growth.
“Other possibilities include the disruption of the normal expression of some proteins, which then subsequently could lead to disruption of normal human function.”
Since biodistribution studies in rats have shown that the mRNA vaccines can accumulate in the reproductive organs, Dr. Ladapo’s letter expressed concern that there may also be DNA integration of reproductive cells.
“We are the most complex beings—the most complex machines, if you will—living machines that exist on this Earth. So I do believe that our genome is part of our connection to God. So that is to say that there’s quite a lot at risk in terms of not taking proper precautions and sensible precautions, with maintaining the integrity to the best that we can—life ain’t perfect, but to the best that we can with our human genome.”
******************************************************
FDA Launches Fresh Bid to Toss Out High-Profile Ivermectin Case
The U.S. Food and Drug Administration (FDA) is seeking to persuade a federal court to dismiss a lawsuit challenging its repeated advisories against using ivermectin to treat COVID-19.
The FDA in a sealed motion asked the U.S. District Court for the Southern District of Texas to dismiss the suit, which was brought by three doctors who allege the FDA’s warnings were illegal.
The late 2023 motion was sealed because exhibits the government cited “include confidential information” from a separate legal proceeding, according to a government brief.
Government lawyers said they would file redacted versions of the motion for public perusal but still haven’t done so.
Attorneys for the doctors said on Jan. 12 that the court should reject the government’s fresh bid to throw out the case.
“The FDA exceeded its authority by repeatedly issuing public directives not to use ivermectin for COVID-19, even though the drug remains fully approved for human use,” they wrote.
The government motion came after an appeals court found that the FDA likely overstepped its authority with the warnings.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ’stop' taking medicine,” U.S. Circuit Judge Don Willett, an appointee of then-President Donald Trump, wrote in the ruling.
The appeals court remanded the case back to U.S. District Judge Jeffrey Brown, who said in 2022 that the doctors failed to prove their allegations.
The FDA in the sealed motion asked Judge Brown, another appointee of President Trump, to dismiss the case.
According to lawyers for the doctors, the FDA’s motion includes the argument that the plaintiffs haven’t suffered injuries that are traceable to the FDA and that can’t be remedied by a ruling in favor of the plaintiffs.
“The FDA is wrong,” the lawyers said. “Plaintiffs have suffered interference with their practice of medicine and the doctor-patient relationship, economic harm, reputational harm, and increased exposure to malpractice liability, and have been subject to disciplinary proceedings and forced resignations, all of which clearly trace to the FDA’s campaign against ivermectin and would be remedied by equitable relief.”
The Federal Food, Drug, and Cosmetic Act enables the FDA to authorize or approve drugs for a specific use, but doctors are free to prescribe cleared drugs for other purposes, in what’s known as “off-label” prescribing. The law doesn’t grant authority to the FDA to regulate off-label use.
The plaintiffs include Dr. Robert Apter, who was investigated by medical boards in two states for prescribing ivermectin to treat COVID-19. The referrals to the boards include some of the FDA’s warnings against using the drug as a COVID-19 treatment.
The FDA’s position in seeking a dismissal stems in part from the negative actions against the plaintiffs being taken by third parties such as pharmacies, according to a description of the sealed motion. It was quoted as saying that the referrals “are not fairly traceable” to the FDA’s statements.
An exhibit included by the FDA, however, showed that one of the referrals came from a pharmacist who cited FDA documents as a reason for “increased scrutiny” with regard to ivermectin prescriptions. The pharmacist wrote that Dr. Apter wouldn’t provide a “valid medical reason” for the ivermectin prescription and was thus engaging in “inappropriate prescribing.”
“The FDA is the common thread through all of [the] plaintiffs’ injuries, which began only after the FDA embarked on its campaign to stop the use of ivermectin for COVID-19 and which often involve explicit invocation of the FDA’s directives and recommendations,” the plaintiffs’ lawyers said.
They are seeking an order that would force the FDA to rescind or amend its warnings. That would remove the justification of the parties that have taken actions against the plaintiffs, the lawyers added.
********************************************************
Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
*********************************************************
Subscribe to:
Post Comments (Atom)
No comments:
Post a Comment