Fifth Circuit sides with ivermectin-prescribing doctors in their quarrel with the FDA

The Food and Drug Administration is not a physician, so it had no business cautioning people not to take ivermectin to ward off Covid-19 infections with social media posts stating, “You are not a horse,” the Fifth Circuit said.

Fifth Circuit sides with ivermectin-prescribing doctors in their quarrel with the FDA
Fifth Circuit sides with ivermectin-prescribing doctors in their quarrel with the FDA

(CN) —Three doctors who prescribed ivermectin for Covid-19 patients have valid claims that the Food and Drug Administration overstepped its authority with a campaign warning people not to take the drug, a Fifth Circuit panel ruled Friday, reinstating the trio’s lawsuit against the agency.

Drs. Robert Apter and Mary Talley Bowden say between them they have treated or consulted more than 9,000 Covid patients and they each have a patient survival rate of more than 99%, despite regularly prescribing them ivermectin off-label to treat the respiratory illness.

But the doctors say pharmacies stopped filling their prescriptions for the drug — which the FDA approved in 1996 for human use to treat parasitic diseases caused by round worms and black flies — after the FDA launched a public relations campaign in spring 2021 sounding the alarm that people were being hospitalized after self-medicating with large doses of the drug intended for deworming livestock that they had purchased over the counter.

The FDA also sent letters to the Federation of State Medical Boards and National Association of Boards of Pharmacy warning against the use of ivermectin to treat Covid-19 with a link to an agency advisory that said taking it in high dosages is dangerous.

Apter and Talley Bowden, along with Dr. Paul Marik, sued the FDA, the Department of Health and Human Services and the agencies’ leaders in Galveston federal court in June 2022. They claimed the FDA had exceeded its authority and violated the Administrative Procedure Act by interfering with their practice of medicine — regulation of which, they contended, falls to states.

The FDA’s campaign, coupled with their advocacy of ivermectin, caused them problems: A major Houston hospital system forced Talley Bowden to resign her privileges; Apter was referred to physician regulatory boards of Arizona and Washington state for discipline; Marik was forced to resign from his post at Eastern Virginia Medical School, where he was a medical professor and chief of pulmonary and critical care.

Marik had developed a Covid-19 management protocol for the university and added ivermectin after finding it was effective treating the illness, especially in the early stages of infection.

After U.S. District Judge Jeffrey Brown dismissed their lawsuit, finding their allegations could not overcome the government’s sovereign immunity, they appealed to the Fifth Circuit.

A three-judge panel of the New Orleans-based appellate court heard arguments last month.

A Justice Department attorney told the panel the FDA “has to be able to make these kinds of public safety statements” about risky uses of drugs, an argument the judges rejected Friday.

Writing for the unanimous panel, U.S. Circuit Judge Don Willett, a Donald Trump appointee, focused on three FDA’s social media posts about ivermectin, in which the agency gave the impression the drug is only meant for horses and cows.

The posts stated: “You are not a horse. You are not a cow. Seriously, ya’ll. Stop it,” “You are not a horse. Stop it with the #ivermectin. It’s not authorized for treating #COVID,” and, “Hold your horses, ya’ll. Ivermectin may be trending, but it still isn’t authorized or approved to treat COVID-19.”

Numerous media outlets published stories about the warnings. But Willett says a key point was lost in the uproar.

“Left unmentioned in most of the messaging: ivermectin also comes in a human version. And while the human version of ivermectin is not FDA-approved to treat the coronavirus, some people were using it off-label for that purpose,” he wrote in the 24-page opinion.

Willett found the Administrative Procedure Act allows the three doctors to bypass the government’s sovereign immunity and assert claims that the two defendant agencies and their top officials acted beyond their authority.

“FDA is not a physician,” Willett wrote in conclusion. “It has authority to inform, announce, and apprise—but not to endorse, denounce or advise. The doctors have plausibly alleged that FDA’s posts fell on the wrong side of the line between telling about and telling to. … Even tweet-sized doses of personalized medical advice are beyond FDA’s statutory authority.” (Emphasis in original.)

The panel — rounded out by U.S. Circuit Judges Edith B. Clement, a George H.W. Bush appointee, and Jennifer W. Elrod, a George W. Bush appointee — reversed dismissal of the lawsuit and remanded it to Brown for further proceedings.

Neither the plaintiffs’ attorney nor the Justice Department responded late Friday to emails seeking comment on the order.

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Stolen water Waging War On Water Rights and BC Food Security

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Health Canada Not Concerned About Scientists’ Finding of Plasmid DNA Contamination in COVID Shots

Health Canada Not Concerned About Scientists’ Finding of Plasmid DNA Contamination in COVID ShotsAfter two scientists independently raised red flags about an inordinate amount of plasmid DNA in the COVID-19 mRNA shots—which they say could potentially alter the human genome—Health Canada did not express concern with the findings, given the testing data provided by the manufacturers. “Health Canada was aware of the presence of residual plasmid DNA as a process-related impurity during review and prior to the authorization of the mRNA COVID-19 vaccines,” the agency said in an email to The Epoch Times. Plasmid DNA is used in the manufacturing of mRNA vaccines and is supposed to be removed to a level below a threshold set by health regulatory agencies before the final product is released for distribution. But microbiologist Kevin McKernan has found the amount of DNA in the injections to be potentially 18 to 70 times higher than the limits set by one regulatory agency. Health Canada didn’t indicate that it has conducted its own testing of the material but says it reviewed the testing data provided by the manufacturers for every vaccine lot. “Health Canada conducts an in-depth independent review of the required evidence provided by the manufacturer to ensure that our high standards for safety, efficacy and quality are met,” it says. The health regulator adds that “it is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies.” Different tests assessing a vaccine property, or the same test conducted in a different laboratory, can produce different results, Health Canada explained. Discovery Mr. McKernan has 25 years of experience in the genomic field and previously worked on the Human Genome Project at MIT. He’s currently the chief scientific officer and founder of the biotech company Medicinal Genomics. In April, he published a paper documenting his research in which he used several methods to test four expired Pfizer and Moderna COVID-19 vaccine vials—which were thought to only contain mRNA—and discovered the presence of double-stranded DNA plasmids. Mr. McKernan found that the quantities of DNA contamination exceeded the European Medicines Agency’s (EMA) 330 ng/mg of DNA to RNA requirement by 18 to 70 times and the U.S. Food and Drug Administration’s 10 ng/dose requirements with a reading of 12 ng/dose. Mr. McKernan warned that the presence of DNA plasmids in the vaccines meant they could potentially integrate into the human genome. Public health agencies have repeatedly claimed that mRNA COVID-19 vaccines do not alter human DNA. “The presence of residual plasmid DNA in the mRNA COVID-19 vaccines does not change the safety assessment of these vaccines by Health Canada,” says Health Canada. The agency added that scientists have been working on plasmid DNA-based vaccines since the 1990s. “Although chromosomal integration of the plasmid DNA was initially a major theoretical concern, the data obtained to date do not support this concern,” it says. ‘I Guarantee You There Has Been Genome Modification’ After Mr. McKernan published his findings, another scientist came to a similar conclusion. During the summer, Dr. Phillip J. Buckhaults, professor of cancer genomics and director of the Cancer Genetics Lab at the University of South Carolina, posted his findings on platform X, previously known as Twitter. Dr. Buckhaults says he found there were up to 2.5 billion molecules of plasmid and about 100-200 billion pieces of plasmid DNA identified by sequencing, per Pfizer dose of 300 microliters (µL) identified by a Polymerase Chain Reaction (PCR) test. This equates to 20 ng/dose, or double the limit set by the FDA and WHO. The PCR test is a laboratory technique for rapidly producing (amplifying) millions to billions of copies of a specific segment of DNA, which can then be studied in greater detail. However, Dr. Buckhaults cautions that the measurements are not very precise and that on one day there will be a reading of 5 ng/dose and on another 10 ng/dose. “There are pieces of plasmid DNA in the vaccine. No one knows if this DNA does anything clinically significant, but it is prudent to check vaccinated people for any evidence of genome modification,” Dr. Buckhaults told The Epoch Times. “If found, it could motivate changing the regulatory guidelines by lowering the limits for allowable DNA in a lipid-nanoparticle based vaccine.” He says he doesn’t believe the manufacturer sought to escape regulations, with the issue rather being the regulatory limits. Dr. Buckhaults adds that 10 ng of contaminating DNA would not be a problem in normal vaccines, as it would be “naked” and “chewed up immediately upon injection.” “Those old regulations may not be appropriate for this new type of vaccine in which the whole point of the vaccine is to wrap the nucleotides (supposedly RNA but now both RNA and DNA) in a protective lipid nanoparticle that will deliver it to the insides of cells. Totally different ballgame.” Dr. Buckhaults, who is not opposed to COVID-19 vaccination and instead seeks to improve it, posted on social media that the plasmid DNA is a potential mechanism for the “rare adverse events that have been observed among vaccinated people.” But he adds that “as of now, this is entirely a theoretical concern.” The molecular biologist also said there was a possibility that plasmids could be causing rare cases of vaccine-induced myocarditis. Dr. Buckhaults said if the needle injecting the vaccine accidentally hit a blood vessel instead of the intended target of muscle, “the plasmid could circulate to other organs and make stable transformants of those cell types, causing long-lasting immunological reaction against those transfected cells.” Dr. Buckhaults said that with hundreds of millions of molecules of DNA plasmids in each 300 µL vaccine dose, there are a “lot of chances for DNA to transfect and integrate.” “Multiply this [number] by the number of arms that it has been put into worldwide, and I guarantee you there has been genome modification. The only question is, how frequently [did this happen] and did it ever do anything bad?” When asked, Health Canada didn’t say if it would attempt to verify the findings made by Dr. Buckhaults and Mr. McKernan and explore the potential consequences to Canadians’ health. It says that the “risk/benefit profile continues to support the use of the Pfizer-BioNTech vaccine,” based on “our evaluation of the data and scientific information.” Concerns With Manufacturing Process In email exchanges with The Epoch Times, Mr. McKernan raised concerns about Health Canada’s stance on the issue. He remarked that Pfizer used a different process to produce the injections for the clinical trials, from which the safety and efficacy data is drawn, as opposed to mass production. He says the “Process 1” used by Pfizer in the trial used a plasmid-free manufacturing method. The production was scaled up using plasmids for “Process 2,” which produced the batches that have been injected on a mass scale. Mr. McKernan wonders how Health Canada can be certain the vaccines are safe if different processes were used. Health Canada said that “Process 1” involves using PCR-amplified, linearized plasmid as a template, yielding clinical materials that are “not entirely plasmid-free,” while “Process 2” uses only linearized plasmid DNA without PCR amplification. They said both processes include steps to degrade the DNA template into fragments and then reduce the quantity of DNA in the final product to less than the approved limit. “Efficacy and safety demonstrated using clinical batches manufactured using ‘Process 1’ are also applicable to commercial batches produced using ‘Process 2,’” Health Canada said. Mr. McKernan told The Epoch Times this response by Health Canada was a “trust me” answer, and questioned why the results measuring the double-stranded DNA contamination were hidden. Health Canada says that it cannot fully review the testing methods used by the manufacturer, given they’re proprietary. “They are not public information. However, the methods used for measuring residual DNA fragments were appropriately validated by the manufacturer and evaluated as fit for purpose by Health Canada,” the health agency said. Mr. McKernan says that in the “absence of transparency” from Health Canada, the public will be “relying on the more transparent work of independent researchers who have not hidden such results.” Patrick Provost, a professor in the Department of Microbiology, Infectious Diseases and Immunology at the Faculty of Medicine of Université Laval, said because Process 2 used a different protocol for large-scale production and included DNA plasmid more proximally and likely at a much higher concentration, the contamination by plasmid DNA could be an issue. Dr. Provost also criticized Health Canada for not “seeming to bother” with independently examining the plasmid DNA digestion and removal process, which he said resulted in “very high levels of plasmid DNA” being detected in the vaccine vials. “Why accept that much DNA in mRNA vaccines? This limit should not be a goal, but a maximum, with the aim of having no DNA at all,” Dr. Provost told The Epoch Times. “Who set that limit, anyway? On what basis? Was that studied at all for biodistribution and safety? “Do the limits set for the DNA contamination of mRNA vaccines consider transfection (via lipid nanoparticles) as the delivery mechanism?” he asked. Genome Integration Through Other Means Concerns about the vaccines being gene-altering therapies have been raised by opponents of mass COVID-19 vaccination but shot down by its proponents, who dispute the “gene therapy” label. The American Society of Gene and Cell Therapy considers the mRNA injections a gene therapy, “because the vaccine introduces new genetic material into cells for a short period of time to induce antibodies.” With regards to whether they can alter the human genome, this hasn’t yet been demonstrated in living individuals, but scientists have found it does during an in-vitro experiment. According to a Swedish study published in February 2022, mRNA from the Pfizer vaccine was reverse-transcribed into human DNA in just six hours during the experiment involving human liver cells. Mr. McKernan mentions the study in his April paper and says that for the mRNA vaccines to integrate into the genome, it would require “LINE-1 driven reverse transcription” as described in the Swedish experiment. But he says that with the double-stranded DNA (dsDNA) contamination he found, “encoding the spike protein wouldn’t require LINE-1 for Reverse Transcription.” “This work does not present evidence of genome integration but does underscore that LINE-1 activity is not required given the dsDNA levels in these vaccines,” he wrote. This view is shared by Bernard Massie, a virologist and former National Research Council acting director general with a sizeable body of research on gene therapy and work on industrial production of therapeutic antibodies and vaccines. “This plasmid DNA doesn’t even need to be reverse-transcribed before integrating itself in the genome,” he told The Epoch Times in a previous interview. Dr. Buckhaults said the U.S. FDA should revisit the topic, in an Aug. 15 post on X. “Have someone look for the presence or absence of plasmid DNA integrated into the genomes of long live stem cells of vaccinated individuals. This is not a crazy idea.” Pfizer did not return a request for comment.