Posted on 01/15/2024 7:29:10 PM PST by SeekAndFind
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 have not 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.
One of the directives said: “You are not a horse. Stop it with the #Ivermectin. It’s not authorized for treating #COVID.”
The government motion came after an appeals court found 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 former 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 arguments that claim the plaintiffs have not suffered injuries that are traceable to the FDA, and that cannot 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 does not 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 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 would not 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 negative actions against the plaintiffs, the lawyers added.
I was diagnosed by my local doc at a nearby ER with viral pneumonia and sent to the ICU for 3 days, before being sent home to die, with an Oxygen machine that did not work and could not provide the 2.5 liters of O2 per minute that had been prescribed. It took 5 days to get that replaced.
His notes from the hospital indicate that he thought I had COVID. He had been prescribing IVM to me for two years, which I used for following the FLCCC Alliance Prevention Protocol.
I went from 195 lbs to 130 during that time and if I left the O2 machine to walk up 13 steps to the main floor of the house, I had to rest in a recliner for 15 - 20 minutes before spending 2 minutes nuking a hot dog before returning to the downstairs bedroom and O2 machine.
When the brain fog began to clear, I did a search for Long COVID online and paid $49 for access to a series of presentations (2.5 days worth) of presentations. As luck would have it, the first presentation was by Dr. Syed Haider, the tele-doc who first prescribed me IVM in 2020. He noted that he had a patient who had not been treated with IVM during a bout with COVID, so he recommended that patient follow the FLCCC Alliance Early Outpatient Protocol, even at that late time frame...and that this had significantly improved that patient’s health.
I still had enough IVM on hand from the Midwest Compounding Pharmacy in Lenexa, KS that he used that I could follow that protocol. After the first 2 double doses of IVM over 24 hours, I felt good enough to shower, dress and drive 30 minutes to my employer to get back on the work schedule.
At 130 lbs, I could not stand for my full 8 hour shift. Fortunately, my 2 days off followed that day, and I ate 5 to 7 Oscar Mayer Smokies & buns every day for months. I am now up to 180 lbs...the remaining weight is lost muscle mass...and can now stand long enough in the kitchen to prepare a proper meal.
The local Quack who had been prescribing me IVM did NOT administer even 1 mg of IVM when I was in the ICU for 3 days (it felt like longer...I have only been able to fill in the blanks since obtaining a copy of the hospital records). He is either stupid or a coward, and basically followed the Fauci policy of withholding IVM or HCQ despite their effectiveness.
IVM has been used for decades and has a better safety record than aspirin...FACT!
If Fauci had acknowledged that HCQ or IVM were safe and effective, there would have been no Emergency Use Authorization for the mRNA injections that kill 1 in 800 people who receive them and injure hundreds more.
Without IVM, I would still be tethered to an O2 machine and might now be dead. At 130 lbs, I looked like I had been in Auschwitz...I am 6’ 2” tall.
I live alone and had been taken to the ER from my employer’s parking lot, after passing out in my car, from the effort of walking to it and getting into it after a manager sent me home an hour early...so the IVM I had at home could not be accessed. My Quack was more interested in getting permission to jam a metal probe up into my upper sinus cavity, potentially injuring the only cells attached to my brain that are capable of cell division. If those cells are damaged or die, a person’s life expectancy is 5 years, max.
The Goverenment agencies that aided and abetted Fauci’s Fraud should all be purged and their execs tried and punished.
Don't forget the Cimetidine (brand name Tagamet®).
Do you have any links handy, on Cimetidibe/cancer?
Thanks!
I was diagnosed with Covid-19 in September 2020. Went to an ER, asked the doctor for a hydroxychloroquine prescription. She refused but was willing to admit me to the hospital. Told her I’d likely die if I agreed to that.
In short, I got hydroxychloroquine from my wife and one of her friends. That, along with Z-pac, a steroid inhaler, and zinc; I felt much better within 12-24 hour and tested negative within five days.
Cimetidine For Cancer Treatment
Repurposing drugs in oncology (ReDO)—cimetidine as an anti-cancer agent
Not really. The FDA now exists for the sole purpose of killing humans and pushing big Pharma's more lucrative poisons.
at issue is the fact that an EUA for the experimental mRNA vaccines REQUIRED that there be no other known treatment for
COVID-19
The “problem” here is that as far back as 2005
https://virologyj.biomedcentral.com/articles/10.1186/1743-422X-2-69
it was KNOWN THAT CHLOROQUINE was a “potent” treatment for SARS-Coronavirus.
This invalidates the premise for the mRNA experimental use authorization (EUA)that was granted by the FDA
Thank you TangoLimaSierra!
“Local doctor prescribed 3mg Ivermectin 4X per day for 3 days. On 4th day he no longer had symptoms.”
That’s interesting — split dose instead of the commonly given 12mg single daily dose. I wonder... Because of your father’s age? Glad it worked!
Yer welcome.
I never heard of a once a day dose of Ivermectin. All those who I spoke with took the same dosage and it was done by weight of the human.
I know many who took it. I do not know a single case where Ivermectin was given that the patient died.
Not saying it did not, but it was effective.
The stupid drug industry tried to stop all of it. Even in my local pharmacy. So we started using Quercetin. It was the over the counter substitute.
In many countries Ivermectin is an over the counter medicine. In most of those countries it is used to treat Malaria. Those countries had the lowest cases of the nations.
The entire medical profession has soiled themselves. Like our lying crooked Fed government, there is no credibility left. This includes our regional hospital. They were always a great medical group. They gave the same lies.
Meanwhile, anyone seen the British tabs?
I’m wondering if CoupFlu vaxxes are about to do a number on the House of Windsor...
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