DRS. MARIK, APTER & BOWDEN SUE THE FDA: "YOU ARE OUTSIDE OF YOUR AUTHORITY."—The FLCCC News Capsule for June 5, 2022
A Compendium of the Latest COVID-19 News, Facts & Features
A lawsuit has been filed against the Department of Health and Human Services by Drs. Robert Apter, Mary Talley Bowden and the FLCCC’s Chief Scientific Officer, Dr. Paul Marik. The plaintiffs argue that the FDA acted outside of its authority and illegally interfered with their ability to practice medicine by directing the public, including health professionals and patients, to not use ivermectin, a drug that has received full FDA approval for human use.
Said Dr. Marik:
“The FDA’s public statements on ivermectin have been misleading and raised unwarranted concern over a critical drug in preventing and treating COVID-19. The agency felt compelled to use language to discourage any discourse and interest in using ivermectin as a front-line treatment of COVID-19. To do this is to ignore both statutory limits on the FDA’s authority and the significant body of scientific evidence from peer-reviewed research, over 80 medical trials, and results from ivermectin’s use in medical settings worldwide, showing the safe and effective use of the drug in fighting COVID-19.
So many questions about the demonstrably fraudulent TOGETHER Trial which mountainous evidence shows was clearly designed to fail. The researchers’ goal? To have the name “ivermectin” struck from the annals of science and uttered nevermore upon the earth.
Let’s consider these queries together.
First, Dr. Pierre Kory poses this question in a Substack post this week: Who are these [Together Trial] investigators?
You have a right to know, especially given their screaming conflicts of interest—at least the ones that were disclosed. They include relationships with Pfizer, Merck, the Bill & Melinda Gates Foundation, the Australian Government, Medicines Development for Global Health, Novaquest, Regeneron, AstraZeneca, Daichi Sankyo, Commonwealth Science and Research Organization, and Card Research.
Then, in another remarkable Substack posting by Alexandros Marinos, the question to be answered is this: Did the TOGETHER trial’s principal investigator admit to dosing patients with high-dose ivermectin before official ethics approval was secured, and did those patients get removed from the published paper?
A newly released email from the TOGETHER trial’s principal investigator, Dr. Ed Mills exposes his white hot lies—again, meant to disabuse anyone of the crackpot notion that ivermectin is an effective, safe, globally available, inexpensive, off-patent drug for the treatment of every phase of COVID-19 disease.
In the email, Mills claims that three-day dosing was already being given to patients on March 6th, noting the fact that this was despite clinicaltrials.gov not being updated. His email acts as confirmation of my conclusion that placebo had started recruitment earlier, but implies something even darker: That patients had been recruited into the treatment arm as well, who were actually getting their dose administered already on March 6th. We have no record of such patients.
We urge you to take the time to read these two outstanding essays. “Buckle your seatbelts because it gets weird, disturbing, and infuriating,” Dr. Kory said.
Boy…does it ever.
In an article published in BizNews, Dr. Colleen Aldous, a healthcare scientist at University of KwaZulu-Natal’s (UKZN) College of Health Sciences where she runs the Doctoral Academy and a member of the Academy of Science of South Africa took the South African Health Products Regulatory Authority (SAHPRA) to task after they announced that: “Given that there is currently no credible evidence to support a therapeutic role for Ivermectin in Covid-19, SAHPRA has decided to terminate the controlled compassionate program with immediate effect.” SAHPRA enabled the program in response to the demand for access to Ivermectin.
Aldous says that SAHPRA referred to two 2021 clinical trials that “do not support the use of Ivermectin for patients with COVID-19” as reasons for the program’s termination. One was the Malaysian I-Tech study and the other? Yep, you guessed it. The TOGETHER trial. Ironically, SAHPRA base their decisions on these two trials which have been shown to be flawed.
“The TOGETHER trial was designed as a coup de gras to crush the Ivermectin debate,” said Dr. Aldous. “There are calls for the TOGETHER trial to be retracted. However, it comes from the New England Journal of Medicine, which appears to be beyond reproach. Ignoring calls for retraction is within their authority. It was also stated that after publication, the data would be made available. Several colleagues have requested the data through the correct channels and have been stonewalled.”
Last week's FLCCC Weekly Webinar introduced the new I-RECOVER: Post-Vaccine Treatment protocol. This week Dr. Marik and Dr. Kory were joined by special guest Dr. Peter McCullough for an information-packed follow-up and Q&A session. Dr. Marik also provided more information and guidance on the benefits of intermittent fasting as part of the new treatment protocol.
Why Won’t the FDA Let Doctors Prescribe Fluvoxamine for Covid? Trials show it keeps patients from getting sicker, but the agency won’t approve its emergency use.
“The FDA has issued many EUAs for novel Covid treatments based on far less evidence.” Read Allysia Finley’s op-ed ‘Why Won’t the FDA Let Doctors Prescribe Fluvoxamine for Covid’ from the Wall Street Journal.
This week, The CDC issued an alert on Pfizer’s oral anti-viral pill Paxlovid, saying that some patients who’ve taken a course of the drug are experiencing a rebound of symptoms after they “recover” from COVID-19. The CDC went on to say that a return of symptoms may be part of the natural course of the coronavirus in patients, "independent of treatment with Paxlovid and regardless of vaccination status."
The CDC maintains that the benefits of taking Paxlovid far outweigh the risks.
“I have never seen rebound with the use of ivermectin, hydroxychloroquine or the combination which is what I most frequently use,” said Dr. Pierre Kory, Chief Medical Officer of the FLCCC. “Further, those two drugs are magnitudes safer than Paxlovid. Ivermectin has many mechanisms of action, one of which is the same as Paxlovid, and I question any pharmaceutical company sponsored trial. I would never use a novel drug based on their data.”
Dr. Paul Marik noted that a recent study from Israel demonstrated that Paxlovid was completely ineffective in high-risk vaccinated patients between the ages of 40-64 years with confirmed SARS-CoV-2 infection during the omicron surge. “Pfizer likely knew that Paxlovid did not work in the vaccinated and removed them from the EPIC-SR trial,” said Dr. Marik. “The high failure rate in the vaccinated and the high relapse rates are likely because Paxlovid is an ineffective drug for the treatment of Covid-19. We are unaware of any reports of rebound infections in patients treated with either ivermectin or hydroxychloroquine.”
1. Arbel R, Sagy YW, Hoshen M et al. Oral nirmatrelvir and severe COVID-19 outcomes during the Omicron surge. Research Square 2022.
When someone says to you, “Why do you believe that ivermectin works for COVID? There’s insufficient evidence!”—please send them THIS LINK. It should help them alight on the path of irrefutable, solid science that has not been dyed, bleached, stained, roasted, boiled, grilled, skewered, or placed in the wood chipper until it emerges as a great big (and life-limiting) lie served up in healing helpings by those whose love of $$$ supersedes that of human life.