That large blimp kind of speaks for itself

https://t.co/IpQM1zSbcm

— Sea lion Defense Brigade (@flipperedfriend) November 25, 2024

"The FDA is not your doctor. Their job is to approve drugs to the market and that's it. They should not be prohibiting drugs. They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit"

purpose of our lawsuit, to remind everybody that the FDA is not your doctor.  Their job is to approve drugs to the market and that's it.  They should be neutral.  They should not be prohibiting drugs.  They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit.  --Dr. Mary Talley Bowden.

“Overwhelming and irreversible damage.” We can’t fix the past but are hoping to prevent this from happening in the future. Thank you @EmeraldRobinson for having us on to talk about our lawsuit against the @US_FDA. @drpaulmarik1 https://t.co/Ga4lOo8nZY

— Mary Talley Bowden MD (@MdBreathe) August 14, 2023

Three doctors who were fired for prescribing or promoting the cheap therapeutic drug, Ivermectin, for the treatment of Covid-19, asked the 5th Circuit Court of Appeals to revive a case that a federal judge dismissed back in December 2022.  

[The judge in this case is The Honorable Priscilla Richmond she's the chief judge for the United States Court of Appeals for the Fifth Circuit.  The date of the hearing was August 8th 2023.]

During the hearing, a justice department attorney named Ashley Cheung Honold tried to defend the FDA's strong campaign against Ivermectin including this tweet where they tell people to just stop it to suggest that the only form of ivermectin comes as horse paste listen

They did not purport to require anyone to do anything or to prohibit anyone from doing what about when it said no stop it why isn't that a command that seems to me that if you were in an English class they would say that is a command stop it that is different than we are providing helpful information.

Your honor, the language that was used in these tweets were merely quips, and I don't think these quips change the substance of the FDA's statement as plaintiffs concede.

Is that a command, "Stop it"?

The tweets about the horse Ivermectin were intended to advise consumers that they should not use Ivermectin intended for animals and that this could be unsafe.

Here is the manipulative ad in question.

You are not a horse. You are not a cow. Seriously, y'all. Stop it. https://t.co/TWb75xYEY4

— U.S. FDA (@US_FDA) August 21, 2021

I'm sorry, can you answer the question, please?  Is that a command, "Stop it"?

Senator Ron Johnson took to Twitter about the about-face of the federal government when confronted with the actual law.  Senator Johnson pointed out that the government admitted in court that the doctors indeed have the authority to prescribe Ivermectin off-label.

Here the FDA was not regulating the off-label use of drugs.  These statements are not regulations.  They have no legal consequences.  They don't prohibit doctors from prescribing Ivermectin to treat Covid or for any other purpose.  Quite to the contrary, there are three incidences that I'd like to point the court to in the record that show that FDA explicitly recognizes that doctors do have the authority to prescribe Ivermectin to treat covid.

So then why are your patients still facing backlashes like this at the drug counter?  "Hi.  I had the same prescription filled at the other store."

Joining us now to discuss these huge developments in the case are two of the plaintiffs Dr. Paul Merrick and Dr. Mary Bowden.  Welcome to you both.  It's good to see you.  This was really big . . . the line of questioning and the struggle to answer from the government lawyer was just amazing.  I'll start with you, Dr. Bowden.  The main argument here is that the FDA admitted to regulating big Pharma.  It doesn't have the authority, though, right, to tell doctors what they can and cannot do, which they acknowledge in court, but if you talk to a doctor, which I did, some of them pretend as if their hands are tied, that they couldn't prescribe Ivermectin.

4:15. There's a misconception that the FDA has more power than they do I think.  The Judge pointed that out quite nicely.  She said, you know, "People believe that the FDA has this power, this right," and that's sort of the purpose of our lawsuit, to remind everybody that the FDA is not your doctor.  Their job is to approve drugs to the market and that's it.  They should be neutral.  They should not be prohibiting drugs.  They shouldn't be endorsing drugs. That's not their role, and that's the point of our lawsuit.

I was quite struck and I played this for my audience on Friday about the argument of sovereign immunity Dr. Merrick.  Essentially the FDA says that we can put out information that's not exactly correct, or that could even harm American citizens and that they have sovereign immunity.  How did you feel about that statement do you believe that's true?

5:19. Yeah, clearly that's absurd.  It means that they are allowed to do anything illegal under the pretense of sovereign immunity.  So let's be clear that the FDA has been on a campaign, a vigorous campaign to deface and dehumanize the use of Ivermectin, which is a safe effective medication, and as a result of this, as you saw in that clip, patients are being denied access to Ivermectin.  Physicians are losing their licenses because they prescribed Ivermectin.  So the misinformation that is being perpetuated by the FDA continues, and as Mary said that is beyond their jurisdiction.  They should not be interfering with the patient-physician relationship.  Their role is to approve drugs they are not in the business of practicing medicine and from the clips that you saw it seems that they're doing a rapid 360 about turns because clearly they made a mistake.

6:30. Yeah, clearly and it seemed like based on what I heard from the hearing, Dr. Bowden, that the judges will likely rule in your favor.  Where do you see this going?  Is the case going to be reinstated?

6:45. Well, unfortunately, the purpose of the lawsuit is basically to have them take down their tweets and take down the misinformation that they put on their website.  Our attorneys don't anticipate that we will get any sort of retraction, although I feel like that is warranted.  We are not seeking damages. Where this goes from here is at the appeal was over sovereign immunity so what may go back to the district court where then we have to prove standing so it's a little up in the air.

7:20. But the damage is already done.  Look if the information is out there. I tried to get Ivermectin for a different purpose than it's used for off-label and the doctor who was willing to prescribe it told me, "Look, don't take this to a local pharmacy.  You got to tell me what pharmacy you're going to take it to because I don't want to hurt my relationship with a pharmacy that I prescribe other medicines, you know, to my local patients."  And that's just absurd.  The damage is done.  If they don't issue a retraction or put out a statement, do you see this war on Ivermectin, Dr. Marick, ever ending, especially as we're we are being warned this other wave of Covid coming? 

8:00. So to speak, the horses are out of the barn already.  They have caused enormous damage.  As Mary said, the purpose of our suit is to prevent them from doing this going forward.  We can't have the FDA interfering with the practice of medicine and that's really the basis of our suit.  But you are correct: the damage that's been done is overwhelming and irreversible.  As you say there is this profound misconception that Ivermectin is horse paste, that it's made for horses, and that it's an unsafe medication.  And those two premises are completely false.  It is one of the safest medications on this planet.  And over 3 billion doses have been given to humans safely, so this is a highly effective medication.  It's exceedingly safe and the notion that it's a toxic horse dewormer is really complete Lee false and misinformation and so the FDA themselves are perpetuating false information and they're interfering with the patient physician relationship.

9:10. Dr Bowden before we end what can people do to help you all fight? 

9:15. Well we're in an information War so keeping the dialogue alive continuing to talk about it continuing to put the heat on the FDA to correct this continue to put the heat on our legislators.  If we lose this case it really emboldens the FDA so it's important and we need to keep talking about it. 

Did you know that Janssen, a J & J division, was from Belgium? Had you known that, would you have taken that, er their, vaccine or any other from a foreign government?

Thank you to Dr. Meryl Nass, dated February 27, 2021.

Yesterday, Feb 26, the FDA’s vaccine advisory committee (VRBPAC), an FDA committee called Vaccines and Related Biological Products Advisory Committee, met to give its assent to the third Covid vaccine candidate applying for an Emergency Use Authorization (EUA). And I spent another day listening in. FDA is expected to authorize use of the vaccine today.

This one requires only one dose.  For now.  The company is doing a clinical trial of two doses and they could be recommended in future. The VRBPAC committee comments were lackluster.  The members had little to go on.  There is no adenovirus vaccine in civilian use in the US, just as there were no mRNA vaccines.  The committee members simply don’t know what they have to watch out for.  One admitted it, and asked if FDA would assist and suggest what types of issues the newly licensed Ebola adenovirus vaccine or the military adenovirus vaccine had faced.  FDA responded with stony silence. Clearly this “advisory” meeting was only needed for its rubber stamp.

Most of the sponsor’s (Johnson and Johnson) presenters were from the Janssen division, based in Belgium. Many of the FDA’s presenters were non-native English speakers. The combination of an audio transmission that kept dropping out, and inability to catch many of the words made it a challenge to fully grasp the presentations. Was this intended? 

This here, is it by will or an omission?  Yeah, that's what I thought . . . .  

FDA has refused to inspect the Covid vaccine manufacturing plants before they are “authorized” under EUA.  I suspect FDA administrators were directed not to slow the warp speed down. 

FDA will have to inspect the factories by law before Covid vaccines are fully licensed, but it seems that the game plan is to get the country vaccinated before adequate data become available and licensure can take place. 

Wait, is she saying that the lack of data is precisely the thing that allows the vax manufacturers to have an emergency permission?

Okay, here is the motherload 

While Johnson and Johnson’s Janssen division designed and tested this new adenovirus vectored spike protein vaccine, the vaccine is actually being produced in a factory newly taken out of mothballs, with hundreds of new employees, that has never before produced a vaccine for mass use.  It is owned by Emergent BioSolutions, a company notorious for poisoning soldiers with its anthrax vaccine, which has failed multiple anthrax vaccine inspections.  On Emergent BioSolutions’ board is Kathryn Zoon, a former head of FDA’s Center for Biologics, which regulates vaccines. 

Here is a vague report.  This was interesting.  Turns out that the vaccine that a company will run in a trial may not be the same vaccine that gets made and distributed to the public.  Wow, we all are making way too many assumptions when it comes to how vaccines are made, their testing, distribution, and so forth.  We're all focused on their efficacy only to find ourselves in a 

This factory’s vaccine may not be exactly the same vaccine that about 20,000 subjects in the clinical trial have received. Usually vaccines for clinical trials are made in a pilot plant under stringent conditions. 

So many questions about the vaccines, where it was made, is the company reputable, do they have major lawsuits against previously deadly vaccines, etc.?  So none of these questions are asked let alone addressed.

Does the vaccine work?  The vaccine is said to be 66% effective against moderate to severe disease in the trials, and 100% protective against death. 

Okay, well, according to Fauci, where most of America got its reports on the vaccines, the vaccines started out at 95% effective and went downhill from there.  

In the clinical trials, having a headache and a cough was enough to put subjects in the “moderate to severe” category.  Like the two mRNA vaccines, the vaccine sponsors apparently did not see fit to test whether their vaccines block infection and transmission in humans. This is the fault of the FDA, which sets the standard for the data needed to obtain an EUA.  

Whoever did this deserves an award.
pic.twitter.com/cJFcgpB9Y3

— Rising serpent 🇺🇸 (@rising_serpent) October 17, 2021

You can find the below video here along with a few remarks by Deborah Birx, who admitted that the vaccines were not going to work.  Imagine that.  While Birx is telling the truth in a rare moment, Dr. Fauci doubled down on his "effective" narrative.  Even recently on the Stephen Colbert Show he praised the vaccines again, while giving a thumbs down to Hydroxychloroquine and warning people that Ivermectin was dangerous.  Ha!  

Apparently in the J&J trials, only a subset of participants were evaluated for side effects, "Only a subset of the subjects in the trials were evaluated for side effects.  Why was that?"  See what Dr. Meryl Nass said about the vaccines in general, 

I can’t tell if this vaccine is safe and I doubt anyone else can, either. Nor do I want to be injected with something manufactured by the anthrax vaccine manufacturer, famed for injuring thousands of soldiers twenty years ago, while making 300% profit margins. 

Read Dr. Meryl Nass's background here.  She's amazing.

Meryl Nass, M.D., ABIM, is an internist with special interests in vaccine-induced illnesses, chronic fatigue syndrome, Gulf War illness, fibromyalgia and toxicology. As a biological warfare epidemiologist, she investigated world's largest anthrax epizootic in Zimbabwe, and developed a model for analyzing epidemics to assess whether they are natural or man-made.  Continue reading . . .