Informed Dissent
Medical Dissidents, Agency Capture, and Dr. Mary Talley Bowden’s Battle with the FDA over Ivermectin
BY M.C. ARMSTRONG | HONEST MEDIA | APRIL 18, 2024
Dr. Mary Talley Bowden recently sued the FDA for stepping beyond their charter, defaming Ivermectin prescribers, and, thereby, interfering with the doctor-patient relationship. Last month, Dr. Bowden resolved her suit, receiving a substantial undisclosed settlement from the government agency.
Dr. Pierre Kory has been an early and staunch defender of the use of Ivermectin to treat COVID-19 in humans. Kory believes the FDA settled this case with Bowden because they had likely hired the PR firm Weber Shandwick to create the now infamous “horse dewormer” campaign (detailed below) to smear Ivermectin and its proponents. If true, once Bowden’s lawsuit went into the phase of discovery then this information would have been revealed, but we will never know since the case is now settled. Weber Shandwick lists the CDC, Pfizer, and Moderna as their clients.
Honest Media covered Ivermectin and the “horse dewormer” controversy in a letter sent to the Associated Press documenting the lies the AP published about the drug. We have also recently received a trove of emails between Dr. Bowden and the Arizona Mirror, an outlet that smeared Dr. Bowden and her colleague, Dr. Peter McCullough. After reviewing them, we can say that these documents illustrate the media’s contempt for medical dissidents.
But why this fear of letting dissenting doctors speak? There has been virtually no coverage of Dr. Bowden’s case. Where there is documentation, like with Jen Christensen’s reporting for CNN, nobody gives voice to the victor and victim, Dr. Bowden. Why?
Dr. Bowden, a Stanford-trained ear, nose, and throat doctor from Houston, has treated more than 6,000 patients suffering from COVID. She is a strong and intelligent woman of science speaking truth to power. Here, in Dr. Bowden, is that “gutsy woman” who Americans were told to admire by leaders like Hillary Clinton. But there’s an implicit caveat in the cult of Clinton’s “gutsy woman:” Such women are to be ignored (and even pilloried and censored) if they challenge the orthodoxies of the Democratic Party or the DNC-aligned Big Pharma industry.
For prescribing Ivermectin and dissenting against the dominant COVID narratives, Dr. Bowden was forced to resign from Houston Methodist Hospital. And she wasn’t the only doctor to face such consequences. Dr. Robert Apter and Dr. Paul Marik, two other Ivermectin physician-advocates, joined Dr. Bowden in her suit against the FDA. Marik, for his part, was forced to resign from Eastern Virginia Medical School as well as Sentara Norfolk General.
Last month, Dr. Bowden traveled to the Supreme Court to stand in solidarity with activists as SCOTUS listened to Murthy v. Missouri. The Murthy case concerns the suppression of medical dissidents, specifically, and online censorship, more broadly. Dr. Bowden addressed the crowd of protesters about her four-year battle with the captured government agency:
How many COVID patients did they examine? How many histories did they take? How many prescriptions did they write? Zero. None of them have cared for a single COVID patient, but because they had the full support of Big Pharma, the government, and, most importantly, the media, they became the scientific authority on a novel disease they had zero first-hand experience in treating.
Bowden has a point. The FDA’s campaign against doctors such as herself gained purchase with the public, in part, because the agency’s claims were amplified by a mainstream media that is shaped and funded – captured – by Big Pharma. Due to the massive influx of advertising dollars and the perfect storm of misinformation and disinformation summoned by Russiagate, the 2020 election, and the COVID-19 pandemic, the American public’s trust in the mainstream media has reached record lows. Bowden’s case reveals another example of why the public is justified in its skepticism.
Let the Doctors Speak
I recently spoke with Dr. Bowden about her fight with the government.
“This was a war on Ivermectin,” she said. “But it was also a war on the doctor-patient relationship.”
I asked her what precipitated the suit against the FDA. Dr. Bowden told me that never before in her career had she witnessed interference with the doctor-patient relationship from the FDA or her local pharmacies. When I asked about prescribing a drug that wasn’t FDA-approved, she told me that she’d often prescribed off-label in the past, with no problems, and that she approached Ivermectin, initially, with hesitancy and skepticism. She said she preferred prescribing monoclonal antibodies at the beginning of the pandemic, but sought new options when access to these treatments became restricted.
“I was nervous to start using it,” she said. “Before I started, I looked at the FDA’s website and the toxicity data. Once I was assured that it worked (maybe not as quickly as monoclonal antibodies), I started offering it to patients.”
Not only did Dr. Bowden prescribe Ivermectin to her patients and witness positive results, but she used it herself. She’s had COVID three times. And in every instance of Ivermectin treatment, both with herself and her patients, she observed either efficacy or minimal side effects.
“I haven’t lost one patient due to Ivermectin,” she said.
In 2015, the Nobel Committee for Physiology honored the discovery of Ivermectin with a Nobel Prize. The NIH lauded this “multifaceted drug,” which was largely unknown in American public discourse prior to the outbreak of the COVID-19 pandemic.
Then, suddenly everyone and their grandmother was an expert on the dangers of Ivermectin. Seemingly overnight, the American people absorbed a viral propaganda campaign from the very government agency (the FDA) that they supported with tax dollars. And if you were a doctor or patient seeking this low-cost, award-winning therapeutic treatment, you were suddenly in the crosshairs of the “war on Ivermectin.” This policing of the poor and the independent all started, according to Dr. Bowden, “with the horse tweet.”
On August 8, 2021, the FDA weaponized its social media account to stigmatize physicians like Dr. Bowden and skeptical and underprivileged patients seeking affordable alternative care. The agency issued a tweet with two images: a veterinarian outdoors caring for a horse, coupled with a physician in an office caring for a masked human. The text for the tweet reads: “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” This tweet, with its careful use of the colloquial and the second person, supplemented with a juvenile binary logic, became the most popular tweet in FDA history.
Hate wins clicks. Fear creates fog. Shortly after the tweet’s publication and viral propagation, Dr. Bowden’s life came undone.
“I never had a pharmacy deny a prescription before,” she said.
Dr. Bowden’s struggle with the pharmacy was just the tip of the iceberg, revealing the stranglehold Big Pharma now has on health care in America. Dr. Bowden suffered (and still suffers) from vicious attacks online, as well as alienation from her peers. She was forced to resign from her workplace, Houston Methodist Hospital. She explained to me that the “war on Ivermectin” was more vitriolic than anything she’d ever seen before in the discourse on public health. And whereas most doctors bent the knee, stayed silent, and complied with government mandates, Dr. Bowden (and others) fought back. Her case represents what one might call a scientific profile in courage.
What does fighting back look like? Well, for starters, perhaps it begins with telling the truth in public and revealing the whole story of Dr. Bowden’s struggle, along with that of fellow medical dissidents like Dr. Kory, Dr. Robert Malone, Dr. Jay Bhattacharya (co-author of the Great Barrington Declaration), and Dr. Peter McCullough.
In Dr. Bowden’s and Dr. McCullough’s recent email exchanges with the Arizona Mirror, one can see, firsthand, a publication that ignores the opportunity to correct factual errors. The Mirror instead willfully litters its reporting on Dr. Bowden and Dr. McCullough with misinformation, ad hominem attacks, bizarre references to Qanon, constant allusions to shadowy conspiracy theories, and the slanderous insinuation that Dr. McCullough is antisemitic.
The Association Fallacy
One of the most recurrent disinformation patterns we have witnessed in studying the defamation of populist voices, broadly, and Dr. Bowden’s case, specifically, is what scholars of rhetoric call the association fallacy. In short, the association fallacy describes claims where even oblique social connection to a stigmatized individual or organization (like QAnon) is used to poison the claims of the targeted speaker. Simply associating the terrifying name of the poisonous organization with the speaker scares the reader and creates an irrational – fallacious – connection.
What’s troubling, in the case of the Arizona Mirror reporting, is that Dr. Bowden and Dr. McCullough have no ties to QAnon. Furthermore, Dr. Bowden and Dr. McCullough both reached out to Jim Small, the paper’s editor, and politely asked that these fallacies be removed from the Mirror’s articles.
For example, Dr. Bowden and Dr. McCullough called attention to the Mirror’s repeated use of the ad hominem “anti-vaxxer” to label Dr. McCullough and associate the doctor with the world of “anti-vaxxers.” In their email exchange, Dr. McCullough confides in Small that he has “accepted dozens of vaccines during the course of my life.”
But the Mirror refused to mirror the truth and remove the slur. The Mirror refused to interview these doctors, refused to correct their reporter’s mistakes when alerted by the victims, and, furthermore, sought to defame the doctors through ad hominem attacks and the association fallacy.
To witness how the association fallacy works, consider the following sentence about Dr. Bowden’s colleague, Dr. McCullough, from the Arizona Mirror’s Jerod Macdonald-Evoy: “McCullough has become a darling to those in both Qanon and the broader conspiracy world, appearing regularly on shows like the one hosted by antisemite Stew Peters, who said the COVID vaccine is a bioweapon.”
In one sentence, the reporter has accused the doctor (without directly accusing him) of antisemitism and conspiracy theory simply by virtue of association with other human beings, mostly unnamed, who populate “the broader conspiracy world.”
What is happening to people like Dr. McCullough and Dr. Bowden rarely happens to those in power. It happens to those who challenge power.
The Arizona Mirror and CNN should be ashamed. They punished informed dissent. They refused to contextualize Dr. Bowden’s struggle as part of a subculture of dignified scientists and physicians. They erased and defamed Dr. Bowden and her colleagues. They published fear porn and called it journalism. They left out this gutsy woman’s voice. Honest Media has chosen a different path. We let the doctor speak.
The FDA Can Say (and Do) Anything It Wants
For example, they can’t be sued for providing false or dishonest information
By John Droz Jr. | Critically Thinking About Select Societal Issues | August 10, 2023
This is an extraordinarily important commentary!
The gist of a current court case that you’ve likely never heard of, is that three heroic doctors are suing the FDA about the loss of their jobs, about their careers being derailed, about the loss of their reputation — all because their professional, scientific opinion as to what was in the best interest of their patients, was different than the political agenda of the FDA. (Here is a bit of background.)
What is at stake here could not be more significant, and it applies across the board to EVERY federal agency. The question is: do federal agencies have the unsupervised right to replace Science with political science? Put another way: can they act dishonestly, incompetently, etc. with essentially no meaningful consequences?
Here is the doctors’ Complaint. Although it was filed a year ago, it is now being appealed this week — and some fascinating audio clips have emerged. There are three judges on a panel, asking the attorney representing the FDA some probing questions.
Five of these short audio clips (3-5 minutes each) are posted here. (The recording of the full proceeding is here.)
IMO some of the key takeaway revelations (so far) are:
1 – The FDA seems to claim that their published warnings are little more than offhand observations. For example, their slamming of Ivermectin was evidently just casual commentary (what the FDA calls “informational”).
Note the title here, on this FDA page which is STILL up! It says “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19”.
Note 1: This is a deceptive headline because that article is mostly saying: a) citizens should not self-medicate, and b) using any veterinary medications can be dangerous. Both of these are legitimate concerns. So, if the FDA was honestly trying to benefit the public their heading should be: “Why You Should Not Self-Medicate Using Veterinary-Grade Ivermectin to Treat or Prevent COVID-19”. BIG DIFFERENCE!
Note 2: This FDA page has changed quite a bit over time. Here is the 2021 version.
Note 3: The current page makes outright false statements like: “Ivermectin has not been shown to be safe or effective for these indications.” I’m one of the few people who has taken the time to put together a spreadsheet of ALL the studies on ALL the major COVID early treatment therapies: see it here.
There have now been 99 Ivermectin scientific studies, and the overall early treatment effectiveness is 62%. IVM’s extensive safety record is extraordinary, with adverse effects (e.g., see here) in the ballpark of only one in a million usages!
Now, also on my spreadsheet, compare what the FDA has approved for early treatment of COVID-19 therapy: Paxlovid = 32% effective with these adverse safety issues, and Molnupiravir = 16% effective with these problematic safety issues!
Despite these LARGE benefits of Ivermectin in effectiveness and safety, the FDA continues to say that “Ivermectin has not been shown to be safe or effective” for early treatment of COVID-19. This is stunningly inaccurate.
Note 4: Even though the FDA now has access to 99 Ivermectin studies, their statement against Ivermectin is stronger now than when the page originally appeared in 2021! IMO this is what happens when a federal agency feels that there is no meaningful oversight, so effectively they can say anything they want.
2 – The FDA says that Courts have no business in reviewing anything they say or do!
Considering the above facts in #1, it’s obvious why this would be their self-serving position. Listen carefully to the second short audio clip, where the FDA’s attorney appears to say that the FDA’s communication to the public can be knowingly false, dishonest, etc. with no oversight or consequences — even when deaths result!
Regretfully, to date, the courts have played along with this game of charades. For example, the Chevron case is frequently cited by non-aggressive attorneys to say that courts will stay out of determining whether FDA processes, documents, and claims are legal, accurate, honest, warranted, etc.
However, that is an oversimplified opinion. Even the Chevron case states that the FDA’s actions must be “reasonable” — but that is rarely argued. BTW, the case we are discussing here would never have been filed if the doctors’ attorneys bought into the bogus idea that federal agencies have unlimited deference. Kudos to them that they did not accept that absurd argument!
Maybe I’m overly optimistic, but based on the judges’ questions and comments in these clips, it seems to me that this case might eventually upend Chevron. That would be EXTRAORDINARILY beneficial for US citizens, as it would apply to all national policies: from immigration to education, energy to climate change, etc.
3 – The FDA asserts that the only recourse that US citizens have about even egregious errors and deceptions by the FDA is through the “political process.” Astounding!
4 – The FDA indicated that the “political process” means that citizens need to elect a competent and attentive President, whose responsibility it is to see that the FDA acts responsibly — or else. The flip side is that when we do not have such a President, all federal agencies have a four-year time period to wreak whatever political havoc that suits them — again, across the board, and without real consequences to the guilty parties.
5 – The FDA’s attorney implied that there would be no compensation given for inaccurate or knowingly false FDA statements — including those that lead to Americans unnecessarily dying — other than an FDA person may lose their job.
6 – Based on these select audio clips, the fact that hundreds of thousands of Americans likely died needlessly due to the FDA’s COVID actions and inactions (see here), was not fully addressed. Hopefully, this will be brought up in this trial.
7 – In clip #3, the FDA attorney makes the startling claim that the FDA has the authority to give citizens medical advice! How is that possible when they know nothing of the medical history of any American citizen? Further, once they assert that right, how is a conflict resolved between what the FDA says and what a citizen’s medical provider says? That is one of the major issues in this important case.
8 – In clip #4, the FDA attorney acknowledges that doctors have lost their jobs, etc. due to their scientific conclusions on such matters as Ivermectin, and their science-based actions that they believed were in the best interest of their patients. However, the FDA attorney then stated that no losses, etc. were due to anything the FDA did. (!)
……….
Note that a lot of the bad behavior with the FDA (and CDC) would be reduced if the Medical Establishment refused to play politics and instead supported real Science for the public. Regretfully, that has not happened and the COVID-19 fiasco exposed this ugly underbelly. See my Report on the COVID failings of the Medical Establishment.
In another Report, I compared the FDA’s approval process for Remdesivir to Ivermectin. This appears to show stunning incompetence at the FDA.
I have made this point before, but it’s worth repeating. The war we are engaged in is that powerful Left-wing forces (exterior and from within) are trying to take America down. One of their primary strategies to do this is to replace Science with political science. That is what this case is about, as the FDA is specifically arguing that they have the right to scrap Science and substitute political science — with impunity!
Draw your own conclusions, but to me, this case is like a Molotov cocktail thrown into the Federal Government bureaucracy. Astoundingly, all three branches of our government are complicit with this nonsense.
Some obvious questions that need to be answered and fixed are: 1) How did Congress give pharmaceutical companies such broad protections against self-serving unscientific actions? 2) How did the Executive branch allow agencies like the FDA to be run by parties that they are supposed to regulate? 3) How did our Judicial system allow bad actor agencies to arrange to have no real legal oversight?
Considering that these failings are applicable to multiple federal agencies, is there any question why such things as COVID policies (and energy, and climate, and education, and immigration, and elections, etc., etc.) are a disaster?
Hopefully, this lawsuit will crack open the door to fixing this horrific mess…
……….
PS — What needs to be done now :
1) Competent attorneys should file friend of the court briefs to support this nationally important case. Overturning the Chevron precedent would have extraordinarily positive benefits for almost ALL US citizens.
2) Competent federal legislators should introduce a “Save America” bill (aka Agency Oversight Act). This legislation will rein in ALL federal agencies, by providing timely and meaningful oversight (plus real penalties) to them all.
Can You Overdose on Ivermectin? Dr. Pierre Kory’s Answer Will Shock You
The Vigilant Fox | Vigilant News | August 17, 2023
“Of all the harmful misinformation spread over the past couple of years, one of the most disturbing false narratives was targeted at the Nobel-Prize-winning, human medicine ivermectin,” expressed filmmaker Mikki Willis in his ground-breaking documentary titled, Ivermectin: The Truth.
Ivermectin is “one of the safest and most effective medicines of this era. A medicine that, according to the numerous top scientists I’ve interviewed … could have ended the pandemic before it began.”
But Ivermectin is “horse dewormer,” the media said. “It could put you in a coma.” “It can kill you,” pundits warned.
But is this actually true?
Popular podcaster Greg Hunter, AKA USA Watchdog, asked Dr. Pierre Kory, one of the world’s leading experts on Ivermectin, straight-up, “Can I OD (overdose) on Ivermectin if I get two or three times the [standard] dose. Can I kill myself?”
“Let me answer scientifically. So there is a world-famous toxicologist named Jacques Descotes, and he’s French. And two years ago, he was commissioned to do a scoping review of the entire data on the safety of Ivermectin in its history. And his conclusion after doing this comprehensive review is that he does not believe that there has been one single case of anyone dying from an Ivermectin overdose.”
Prof. Jacques Descotes: Image – Academica.edu
“Oh, Lord,” reacted Greg Hunter. “How many pills have been given worldwide? I heard 4 billion, but it must be more than that.”
“Over 4 billion,” Dr. Kory confirmed. “Now, people have died where the deaths were reported as caused by Ivermectin. But when he [Prof. Jacques Descotes] reviewed those cases, he didn’t think those arguments [were] credible.”
Let’s dive deeper into Prof. Descotes’ analysis.
But first, a quick look at his impressive credentials. “Pr. Jacques Descotes, MD, PharmD, PhD, Professor Emeritus, Claude Bernard University of Lyon (France), [is] a world-known toxicologist with a 40-year track [record] as an independent consultant for the pharmaceutical industry as well as an advisor to regulatory bodies worldwide,” BusinessWire wrote.
In March 2021, he conducted a review of Ivermectin’s safety profile based on over 350 articles – plus accessible web sources. Here are his conclusions:
“Ivermectin has been administered orally to hundreds of millions of people throughout the world in the past three decades. The assessment of reported adverse events temporally associated with Ivermectin exposure shows that Ivermectin-induced adverse effects have so far been infrequent and usually mild to moderate.
“It is noteworthy that no deaths have seemingly ever been reported after an accidental or suicidal overdose of Ivermectin. No greater toxicity of Ivermectin has been substantiated in elderly people despite repeated assertions that an ageing blood-brain barrier might lead to increased Ivermectin toxicity level. The positive clinical experience accumulated with Ivermectin administration led many medical experts to break away from early adamant contra-indications in pregnant women. Finally, several national pharmacovigilance networks around the world released information and opinions to ascertain Ivermectin safety in human subjects. So far, there are no critical safety limitations to Ivermectin prescription in current indications.
I also want to point out that no severe adverse event has been reported in dozens of completed or ongoing studies involving thousands of participants worldwide to evaluate the efficacy of Ivermectin against COVID-19.”
“In order to overdose from Ivermectin, you have to take either a hundred or a thousand times the standard dose,” declared Dr. Kory.
“And there have been accidental poisonings where people have taken large amounts. But you know what happens every time? When they take these massive amounts of Ivermectin, it tends to affect them neurologically. They’ll get confused. They might be stumbling — uncoordinated. They go to the hospital, and there’s no treatment required. But within days, the patients return to normal. So, there’s been no life-ending injuries. No deaths reported with Ivermectin. So, that shows you why it’s one of the safest drugs in history, even at massive overdoses.
Greg Hunter’s full interview with Dr. Pierre Kory is available to watch.
U.S. Lawyers Reiterate Claim Ivermectin was never prohibited for treating COVID-19
Attorneys restate claim that FDA merely advised doctors against IVM for dying patients, but did NOT prohibit it.
BY JOHN LEAKE | COURAGEOUS DISCOURSE | AUGUST 14, 2023
Last November, I wrote the following post:
The Epoch Times recently reported an astonishing statement by a U.S. government lawyer in a federal court in Texas, where the FDA is being sued by Dr. Paul Marik of Virginia, Dr. Mary Bowden of Texas, and Dr. Robert Apter of Arizona. The three plaintiffs claim the FDA illegally prohibited them from prescribing the drug to their patients. At a November 1 hearing, U.S. lawyer Isaac Belfer argued for the defendant:
The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
If Belfer’s assertion is true, it raises a very urgent question: On what legal grounds did hospitals all over the United States refuse to administer ivermectin to severely ill COVID-19 patients, even when patients and their family members begged for the drug to be administered?
If ivermectin was not prohibited by the FDA or any other U.S. medical authority for treating COVID-19, why did Dr. Paul Marik’s hospital prohibit him from administering the drug to his dying patients? Why was Dr. Mary Bowden reported to the Texas Medical Board for disciplinary action when she prescribed it? Why did many pharmacists fear losing their licenses if they filled ivermectin prescriptions for treating COVID-19?
In our book, The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex, Dr. McCullough and I document numerous instances of hospitals flatly refusing to grant the wishes of dying patients and their family members for ivermectin.
All these patients asked for was to be allowed to try the drug (FDA-approved for River Blindness, Elephantiasis, and Scabies) for COVID-19. The patients and their kin gladly indemnified the hospitals and arranged to have their independent primary care doctors deliver and administer the drug. Nevertheless:
- Hospital administrators absolutely refused to grant this wish.
- Hospital attorneys fought tooth and nail against using ivermectin to treat COVID-19 patients, doing everything in their power to challenge patient lawsuits and appeal court orders to administer the drug.
- Even when hospital doctors acknowledged that the patients were dying, they insisted it was better to let the disease take its natural course rather than allow patients to try ivermectin.
- Even when patients’ families succeeded in getting a court orders to administer the drug, many hospitals still refused, even at the risk of being held in contempt of court.
Several readers have told us that our chapters covering this shameful scandal— Chapters 38: Begging for the Wonder Drug and Chapter 40: Graduating into Eternity—are horrifying beyond belief.
Now we hear U.S. government lawyers arguing in court that the FDA never prohibited using ivermectin to treat COVID-19 patients, but merely recommended not using it. This indicates that hospitals had no legal grounds for denying sick patients a drug that could have helped them. How is withholding medicine from a sick man any different from withholding a life ring from a man who has fallen overboard in high seas?
For families who watched their loved ones slip away after being denied the right to try ivermectin, U.S. attorney Isaac Belfer’s statement may be interpreted as declaring open season for lawsuits against hospital administrators and doctors.
After I wrote the above post, I exchanged an e-mail with Dr. Marik in which he expressed profound discouragement about U.S. Judge Jeffrey Vincent Brown’s granting of the government’s Motion to Dismiss the case on the grounds of sovereign immunity.
Nevertheless, Dr. Marik and his co-plaintiffs, Robert L. Apter and Mary Talley Bowden, appealed the dismissal and are now being heard before a three-judge panel of the 5th U.S. Circuit Court of Appeals.
Once again, attorneys for the U.S. government are in the hot seat about their mendacious claims about the FDA’s directive to doctors and hospitals against prescribing or administering Ivermectin, either to outpatients or to patients dying in hospital.
Instead of acknowledging the obvious reality that the FDA did indeed DIRECT doctors and hospitals against administering Ivermectin, U.S. attorneys continue to insist that the FDA’s communiques were mere advice.
This preposterous argument not only overlooks the plain language of the FDA’s communiques, it also overlooks the salient fact that numerous doctors (like Paul Marik) were fired from their jobs for administering ivermectin to their dying patients, and the fact that many State Medical Boards revoked doctors’ licenses for doing the same. If these punitive actions taken against doctors were NOT based on the FDA’s directives, on what grounds were they taken?
As was just reported by Just the News columnist Greg Piper:
The 5th Circuit panel seemed skeptical of Civil Division Appellate Attorney Ashley Honold’s argument that the FDA’s “informational statements” against ivermectin, including its conflation of human and animal dosages, were “merely quips” about reported problems after “self-medicating” rather than “prohibit[ing] anyone” from using ivermectin.
Judge Jennifer Walker Elrod cited the phrase “Stop it” in the agency’s viral “You are not a horse” post on X, then known as Twitter. “If you were in English class, they would say that was a command. … That is different than ‘we’re providing helpful information,'” she told Honold.
Readers of this Substack will probably agree with my sentiment that enough is enough of lying and obfuscating U.S. government agency officials and their mercenary lawyers. It’s time for the grown-up, reasonable citizenry of this country to join Marik, Bowden, et al. in suing the pants off the FDA and other U.S. agencies against whom there is a preponderance of evidence that they have unlawfully interfered with the doctor-patient relationship and committed negligent homicide, fraud, and concealment.
Cry havoc and let slip the plaintiffs’ attorneys! Sue the FDA; sue doctors and hospital administrators; and sue the medical boards. Let them pay for the damages they have inflicted on the families of patients who were denied ivermectin until their last breaths. Let them pay for the massive damage and distress they have caused for courageous doctors like Paul Marik and his colleagues who tried to help their patients.
U.S. Lawyers Claim Ivermectin was never prohibited for treating COVID-19. FDA merely recommended not using it.
No legal prohibition authorized or justified hospitals to withhold the drug from dying patients. Let the lawsuits begin.
FDA tweet against using ivermectin. Not a prohibition, merely a recommendation.
By Dr. McCullough & John Leake · Courageous Discourse · November 22, 2022
The Epoch Times recently reported an astonishing statement by a U.S. government lawyer in a federal court in Texas, where the FDA is being sued by Dr. Paul Marik of Virginia, Dr. Mary Bowden of Texas, and Dr. Robert Apter of Arizona. The three plaintiffs claim the FDA illegally prohibited them from prescribing the drug to their patients. At a November 1 hearing, U.S. lawyer Isaac Belfer argued for the defendant:
The cited statements were not directives. They were not mandatory. They were recommendations. They said what parties should do. They said, for example, why you should not take ivermectin to treat COVID-19. They did not say you may not do it, you must not do it. They did not say it’s prohibited or it’s unlawful. They also did not say that doctors may not prescribe ivermectin.”
If Belfer’s assertion is true, it raises a very urgent question: On what legal grounds did hospitals all over the United States refuse to administer ivermectin to severely ill COVID-19 patients, even when patients and their family members begged for the drug to be administered?
If ivermectin was not prohibited by the FDA or any other U.S. medical authority for treating COVID-19, why did Dr. Paul Marik’s hospital prohibit him from administering the drug to his dying patients? Why was Dr. Mary Bowden reported to the Texas Medical Board for disciplinary action when she prescribed it? Why did many pharmacists fear losing their licenses if they filled ivermectin prescriptions for treating COVID-19?
In our book, The Courage to Face COVID-19: Preventing Hospitalization and Death While Battling the Bio-Pharmaceutical Complex, Dr. McCullough and I document numerous instances of hospitals flatly refusing to grant the wishes of dying patients and their family members for ivermectin.
All these patients asked for was to be allowed to try the drug (FDA-approved for River Blindness, Elephantiasis, and Scabies) for COVID-19. The patients and their kin gladly indemnified the hospitals and arranged to have their independent primary care doctors deliver and administer the drug. Nevertheless:
- Hospital administrators absolutely refused to grant this wish.
- Hospital attorneys fought tooth and nail against using ivermectin to treat COVID-19 patients, doing everything in their power to challenge patient lawsuits and appeal court orders to administer the drug.
- Even when hospital doctors acknowledged that the patients were dying, they insisted it was better to let the disease take its natural course rather than allow patients to try ivermectin.
- Even when patients’ families succeeded in getting a court orders to administer the drug, many hospitals still refused, even at the risk of being held in contempt of court.
Several readers have told us that our chapters covering this shameful scandal— Chapters 38: Begging for the Wonder Drug and Chapter 40: Graduating into Eternity—are horrifying beyond belief.
Now we hear U.S. government lawyers arguing in court that the FDA never prohibited using ivermectin to treat COVID-19 patients, but merely recommended not using it. This indicates that hospitals had no legal grounds for denying sick patients a drug that could have helped them. How is withholding medicine from a sick man any different from withholding a life ring from a man who has fallen overboard in high seas?
For families who watched their loved ones slip away after being denied the right to try ivermectin, U.S. attorney Isaac Belfer’s statement may be interpreted as declaring open season for lawsuits against hospital administrators and doctors.
Stop the War on Doctors
My Rather Public Reply To The Threat Made Against Me By The American Board Of Internal Medicine
By Pierre Kory | July 2, 2022
Anyone in America who deviates from the group-think enforced by public health bureaucrats runs the risk of cancellation. Politicians, parents, comedians, teachers – now they’re even coming for the doctors.
As a lung and ICU specialist, I have practiced medicine for 14 years and successfully treated more than 450 patients during the pandemic. Long before anyone had heard of Covid-19, I was studying and implementing cutting-edge methods to treat critically ill patients. I’m the Senior Editor of a best-selling textbook in my field, now in its second edition, which has been translated into seven languages.
For my efforts, I now find myself on the receiving end of “disciplinary sanctions” from the American Board of Internal Medicine (ABIM), who sent me a letter threatening “suspension or revocation of board certification.”
The “sin” threatening to end my medical career was my unwillingness to go along with Fauci’s monolithic vaccines-above-all-else strategy. The failure of this approach is plain to see, and anyone with an ounce of curiosity knows there are many methods of treating the virus.
Ivermectin is one of them. This cheap, readily available generic medicine is approved by the FDA for certain uses in humans – but not for Covid-19, despite 85 controlled trials from around the world demonstrating its effectiveness. In Brazil, the largest study to date found a reduction in Covid mortality rate of 70%. In India, the second most populated country in the world, the drug has been credited with near eradication of the disease. Studies attempting to discredit ivermectin have been debunked again and again.
Other trials, such as the recent TOGETHER trial, are designed to fail from the start to drive a desired narrative. In the National Institutes of Health’s ACTIV-6, despite starting the majority of patients on treatment after five days of Covid-19 symptoms at a lower than recommended dose, they found a statistically significant reduction in the time to recovery, particularly among the most severely ill. Unsurprisingly, major newspapers reported that the study showed ivermectin was ineffective.
Despite ivermectin’s proven effectiveness, in the opinion of the ABIM, advocating for its usage is a form of “disinformation” and carries the penalty of losing one’s medical license and livelihood.
Throughout the pandemic, I’ve maintained an open mind, analyzed what works for patients, discussed strategies with fellow doctors, and conducted my own extensive research. When new data arose that changed my understanding, I admitted as much and changed course—like with the vaccines. If only the powers that be at the ABIM and our government could say the same.
Consider the evolution of accepted facts about Covid-19 safety measures from Fauci and his ilk. Despite government mandates, neither lockdowns nor cloth masks prevent transmission. They never have. It turns out former Surgeon General Jerome Adams had it right when he tweeted in March 2020 that masks are, “NOT effective in preventing general public from catching #Coronavirus” – a comment for which he was pilloried. We are only beginning to learn the impact of the societal costs of these early preventative measures, a price our children who were kept home from school will be paying for years.
Second, there is no evidence the vaccines stop Covid-19, despite the constant lecturing from the Biden Administration and the mainstream media. In the United States and globally, cases continue to rise and fall without any correlation to the pace or percentage of population vaccinated. This is not what we were promised. In 2021, Fauci said vaccinated people were “dead ends” for the virus, and President Biden declared, “You’re not going to get COVID if you have these vaccinations.” Today, approximately 110,000 cases are announced daily in America, where more than two thirds of the population is fully vaccinated.
There is a backlash brewing in America right now, and it goes beyond inflation rates and gas prices. People are tired of arrogant public officials and compromised institutions who believe they have all the answers but constantly get it wrong and make no apologies as they steamroll those who don’t support the current narrative. The ABIM’s sudden (and suspiciously well-funded) persecution of doctors who stray from the party line is only the latest example.
Doctors on the ABIM’s board and across the country need to stand up against this witch hunt. It’s demeaning to honest doctors and dangerous to the patients we’ve dedicated our careers to serving.
Pierre Kory, M.D., is president and chief medical officer of the Front Line COVID-19 Critical Care Alliance.
Ivermectin Study’s Negative Conclusion is at Odds With Its Findings of Significant Clinical Benefit
BY WILL JONES | THE DAILY SCEPTIC | JUNE 21, 2022
A new study on cheap, repurposed Covid treatment ivermectin has concluded that its findings “do not support the use of ivermectin to treat mild to severe forms of COVID-19”. However, this conclusion is at odds with its findings.
The study, “Non-effectiveness of Ivermectin on Inpatients and Outpatients With COVID-19; Results of Two Randomised, Double-Blinded, Placebo-Controlled Clinical Trials”, is published in Frontiers in Medicine. It includes among its authors Dr. Andrew Hill, who last year appeared to suggest to Dr. Tess Lawrie that pressure had been applied to him not to find in support of ivermectin in an earlier paper. He told her, “I’m in a very sensitive position here”, and “I don’t really want to get into” revealing who from Gates-funded charity Unitaid, which funded the study, really wrote the conclusion of the paper downplaying the benefits of the treatment.
The new study gives a helpful introduction to the drug.
Ivermectin is a low-cost established drug with clinical benefits and minimal safety concerns, which has been shown to inhibit SARS-CoV-2 in vitro in studies. Ivermectin has rapid oral absorption, with high lipid solubility is widely circulated in the body, metabolised in the liver, and excreted in faeces. The adequate concentration of ivermectin inhibiting SARS-CoV-2 in the in vitro experiment is higher than the approved dose of ivermectin concentration in plasma and the lungs of humans. However, a meta-analysis demonstrated that the administration of a standard FDA-approved dose shows a positive clinical response in COVID-19 patients.
The study is a follow-up to an earlier, smaller study which showed promise. However, the promise has not, the authors say, been borne out.
Despite our previous more favourable results from a multicentre, randomised clinical trial in 69 COVID-19 patients at the beginning of the pandemic which noted the effectiveness of ivermectin in recovery and decreasing duration of hospital stay, the current results of this extensive study on 609 admitted patients with moderate to severe form of COVID-19 and 549 outpatients with a mild form of COVID-19, did not show adequate support for the effectiveness of this drug.
Despite this downbeat assessment, the new study did actually find a significant 32% improvement in ivermectin hospital patients achieving complete recovery, with 37% of ivermectin patients vs 28% of placebo patients achieving the outcome [95% CI, 1.04–1.66].
A number of the other key outcomes, including ICU admission and death, were also better in the ivermectin group, though the study was underpowered (not large enough) for these results to be statistically significant (i.e., we can’t be sure they weren’t coincidence). These were:
- ICU admission: 28 ivermectin vs 32 placebo patients; 9% vs 11%; 16% improvement [95% CI, 0.52–1.36].
- Invasive mechanical ventilation: 3% ivermectin vs 6% placebo; 50% improvement [95% CI, 0.24 –1.07].
- Supplemental oxygen by non-invasive ventilation: 244 ivermectin vs 252 placebo; 78% vs 85%; 7% improvement [95% CI, 0.86–1.00].
- Death: 13 ivermectin vs 18 placebo; 4% vs 6%; 33% improvement [95% CI, 0.35–1.39].
The fact that all these outcomes showed an improvement, and mechanical ventilation and death considerably so, is a signal that the benefit is unlikely to be solely due to chance. Thus the conclusion should really have been that a larger study is needed to see if the promising results can achieve statistical significance.
For outpatients, there were also some significant clinical benefits:
- Fever duration: 2.02 (± 0.11) days ivermectin vs 2.41 (± 0.13) days placebo; 16% improvement.
- On the day seventh of treatment, fever, cough and weakness were significantly higher in the placebo group compared to the ivermectin group.
A few results went the other way, though none of these were statistically significant. For inpatients:
- Length of hospital stay: 7.98 (± 4.4) days ivermectin vs 7.16 (± 3.2) days placebo; 20% worse [95% CI, 0.15–1.45]. The study claims this finding is “significant”, but the wide confidence interval going through 1.0 indicates not. The authors write that “delays in discharging patients to other facilities such as rehabilitation centres… might be the reason for more extended hospital stay other than treatment for COVID-19”.
- Mean oxygen saturation at day seven: 92.01 (Range: 72–99) ivermectin vs 93 (Range: 48–99) placebo; 1% worse [95% CI, –2.89 to 0.91].
- Relative recovery (where some symptoms persist on discharge): 53% ivermectin vs 60% placebo; 13% worse [95% CI, 0.76–1.00].
- Persistent dry cough (until seventh day): 5 ivermectin vs 10 placebo; 3% vs 9%; 36% worse [95% CI, 0.13–1.03].
For outpatients:
- Hospitalisation: 7% ivermectin vs 5% placebo; 36% worse [95% CI, 0.65–2.84].
- PCR negative on day five after treatment: 26% ivermectin vs 32% placebo; 19% worse [95% CI, 0.60–1.09].
The authors write that “no evidence was found to support the prescription of ivermectin on recovery, reduced hospitalisation and increased negative RT-PCR assay for SARS-CoV-2 five days after treatment in outpatients”. However, it’s important to note that this was for ivermectin given more than a week after symptoms began. Proponents of ivermectin often argue that treatment should be given within five days of exposure, i.e., as soon as possible.
The paper does mention this issue, though in a strange sentence with typographical errors perhaps indicative of a late addition: “Ivermectin may be going to be effective if it is given at the earliest possible time that clinical symptoms appear whiles [sic] the mean duration of symptoms before randomisation was 7.36 ± 3.43 days in the ivermectin group and 6.98 ± 3.63 days in the placebo group.” Typographical errors aside, the point is correct; an outpatient study really needs to start the treatment sooner.
There may also be a dosage issue. While the trial gave a dose of 0.4 mg per kg per day over a duration of three days, some have suggested a higher dose is required. The paper nods at this where it says: “Krolewiecki et al. assessed antiviral activity and safety of a five-day regimen of high dose ivermectin, comparing the control group in 45 patients with COVID-19. The findings support the hypothesis that ivermectin has a concentration-dependent antiviral activity against SARS-CoV-2.”
A further potential problem with the study, which was conducted in Iran where ivermectin has been popular as a Covid treatment, is the question of how many of the placebo group were also secretly taking ivermectin anyway. In the limitations the authors note that “after the allocation of ivermectin or placebo, a significant number of patients declined to be participants”, which may be because they realised they wanted to be sure they were taking the drug. Taking an antiviral medication was an exclusion criterion for outpatients – 18 admitted to it, but how many continued with the trial (for which they were presumably paid) but took such drugs anyway? Furthermore, previously taking an antiviral does not appear to have been an exclusion criterion for inpatients, so it is unknown how many placebo-arm inpatients had taken ivermectin or another medication prior to hospitalisation. Once in hospital, I imagine they would not have been able to continue taking any medication secretly, and perhaps that explains why nearly a third of the inpatient participants were lost to follow up, most due to voluntary withdrawal or “incomplete intervention” (31.6%, 282 of 891; 136 ivermectin and 146 placebo).
Overall, I find the conclusion baffling given the findings. There were statistically significant benefits of ivermectin for complete recovery, shorter duration of fever and quicker clearing up of cough and weakness. There were also large but not-statistically-significant benefits for mechanical ventilation and death. The negative findings were mostly small and none were statistically significant. This is for a study which didn’t start the treatment until over a week into symptoms, and may have been confounded by people in the placebo arm also taking the drug.
Perhaps we will never get to the bottom of exactly how effective ivermectin is against COVID-19. But since it’s a safe drug (to quote U.K. Chief Medical Officer Chris Whitty, “Ivermectin has proven to be safe. Doses up to 10 times the approved limit are well tolerated by healthy volunteers”) and this study shows once again that it gives some benefit – other studies show much greater benefit – why not be honest about that, allow medics to include it in their treatment protocol, and stop making such a fuss about stopping them?
Doctors Sue FDA, Allege Crusade Against Ivermectin ‘Unlawfully Interfered’ With Their Ability to Treat Patients
The Defender | June 6, 2022
Three physicians are suing the U.S. Food and Drug Administration (FDA) for launching what they allege is a “crusade” against ivermectin as a treatment for COVID-19 that “unlawfully interfered” with the doctors’ ability to practice medicine.
In a lawsuit filed June 2, Drs. Robert L. Apter, Mary Talley Bowden and Paul E. Marik argued the FDA acted outside of its authority by directing the public, including health professionals and patients, to not use ivermectin — even though the drug is fully approved by the FDA for human use.
The suit, filed in the U.S. District Court, Southern District of Texas, Galveston Division, also names the U.S. Department of Health and Human Services (HHS), HHS Secretary Xavier Becerra and Robert Califf, acting FDA commissioner.
According to the complaint:
“The FDA generally cannot ban particular uses of human drugs once they are otherwise approved and admitted to the market, even if such use differs from the labeling — commonly referred to as ‘off-label’ use.
“The FDA also can not advise whether a patient should take an approved drug for a particular purpose. Those decisions fall within the scope of the doctor-patient relationship.
“Attempts by the FDA to influence or intervene in the doctor-patient relationship amount to interference with the practice of medicine, the regulation of which is — and always has been — reserved to states.”
The plaintiffs said their lawsuit isn’t about whether ivermectin is an effective treatment for COVID-19. It’s about who determines the appropriate treatment for each unique patient and whether the FDA can interfere with that process.
In their complaint, they site an FDA publication, “Why You Should Not Use Ivermectin to Treat or Prevent COVID-19,” and tweets from the FDA — including one implying that ivermectin is intended only for animals — among examples of the FDA discouraging the use of ivermectin.
The plaintiffs also argued if the FDA is allowed to interfere with the practice of medicine now, using the pandemic as a cover, “this interference will metastasize to other circumstances, destroying the carefully constructed statutory wall between federal and state regulatory powers, and between the FDA and the professional judgment of health professionals.”
“This lawsuit, brought by three eminently qualified physicians, is a welcome development,” said Mary Holland, Children’s Health Defense president and general counsel.
Holland told The Defender :
“These doctors rightfully assert that the FDA, assisted by corporate media, have unlawfully interfered in the doctor-patient relationship and the appropriate treatment for individual patients. Regulating the doctor-patient relationship is an area of well-established state, not federal, law.
“I hope these plaintiffs will enjoin the FDA from continuing to restrict access to ivermectin and from penalizing healthcare practitioners who use this licensed drug for their patients.”
The plaintiffs: well-respected in their field, high success rate treating COVID patients
Apter, who is licensed to practice medicine in Arizona and Washington and has a COVID-19 patient survival rate of more than 99.98%, was referred to the Washington Medical Commission and Arizona Medical Board for disciplinary proceedings for prescribing ivermectin to treat COVID-19.
In a press release, Apter said, “If doctors are freed to treat patients according to their best judgment and unprejudiced evaluation of the medical literature, many thousands more deaths and serious disabilities will be averted.”
Apter said the FDA’s pronouncements against the use of ivermectin “have been the basis for disciplinary actions against doctors, interfere with the doctor-patient relationship, and have had a severe chilling effect on the use of life-saving medication for a deadly disease.”
In the lawsuit, Apter argued that government pressure, “largely through the FDA,” also led pharmacies — especially in large corporate chains — to refuse to fill ivermectin prescriptions for COVID-19, because that position is supported by the FDA.
Bowden, who according to the lawsuit has 40 years of experience in emergency medicine, began recommending ivermectin to treat COVID-19 in early 2020. She treated more than 3,900 patients for COVID-19, with a success rate of over 99.97%.
She said the FDA’s actions regarding ivermectin, specifically its directives to stop using the drug to treat COVID-19, harmed Bowden’s ability to practice medicine and treat patients.
Bowden’s employer, Houston Methodist Hospital, last year forced her to resign by suspending her privileges for spreading “COVID misinformation.”
Bowden said she is “fighting back — the public needs to understand what the FDA has done is illegal, and I hope this suit will prevent them from continuing to interfere in the doctor-patient relationship.”
In an interview earlier this year with The Defender, Bowden said she was all for the COVID vaccines when they first came out — it was only when she started seeing what was happening with all the breakthrough cases that she wondered, “Why am I seeing so many COVID cases among the fully vaccinated?”
Then her patients began having adverse reactions. “If I hadn’t seen that firsthand, I would still think the vaccine was the way to go,” she said.
As the pandemic evolved, Bowden developed protocols for preventing and treating COVID patients. She said she’s seen excellent results.
“The basis of it is ivermectin,” she said. “And also vitamins C and D, quercetin and zinc, and black seed oil. It’s nothing complicated — and it’s just like with anything in medicine — not one size fits all — protocols are guidelines.”
The controversy over prescribing ivermectin was initially “intimidating and isolating,” she said. “I thought I was a little bitty island in a huge ocean, and now I realize that I’m part of at least half a continent.”
Marik, author of more than 750 publications, was professor of medicine and chief of pulmonary and critical care medicine at Eastern Virginia Medical School (EVMS) in Norfolk, Virginia, from 2009 through 2021. He also served as a director of the intensive care unit at Sentara Norfolk General Hospital.
He developed a protocol for EVMS for treating COVID-19, called the EVMS COVID-19 Management Protocol, which included the MATH+ Protocol.
However, according to the lawsuit, Marik was forced to resign from his positions at EVMS and Sentara Norfolk General Hospital for promoting the use of ivermectin — “as well as other safe, cheap, and effective off-label FDA-approved drugs” — to treat COVID-19 following the FDA’s attempts to stop use of those drugs for that purpose.
Marik alleged in the lawsuit that refusing to allow patients to receive effective early treatment for COVID-19 “led to innumerable hospitalizations and deaths, and caused extreme distress for patients, their families, and health professionals.”
Boyden, Gray & Associates, a Washington, DC-based law firm, is representing the plaintiffs.
Ivermectin was developed in the 1970s as a veterinary medicine to treat parasitic diseases in livestock, but a decade or so later was hailed as a “wonder drug” and received approval for human use as a therapeutic against diseases such as river blindness — or onchocerciasis — and lymphatic filariasis, according to Newsmax.
Since 1987, it has been used safely in 3.7 billion doses worldwide. William Campbell and Satoshi Omura won the 2015 Nobel Prize in Physiology or Medicine for their research on the drug.
Studies show ivermectin is associated with lower COVID-19 death rates, but the FDA — with help from mainstream media — continues to state the drug is ineffective for treating COVID.
© 2022 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.
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From the Archives
The lies about the 1967 war are still more powerful than the truth
By Alan Hart | June 4, 2012
In retrospect it can be seen that the 1967 war, the Six Days War, was the turning point in the relationship between the Zionist state of Israel and the Jews of the world (the majority of Jews who prefer to live not in Israel but as citizens of many other nations). Until the 1967 war, and with the exception of a minority of who were politically active, most non-Israeli Jews did not have – how can I put it? – a great empathy with Zionism’s child. Israel was there and, in the sub-consciousness, a refuge of last resort; but the Jewish nationalism it represented had not generated the overtly enthusiastic support of the Jews of the world. The Jews of Israel were in their chosen place and the Jews of the world were in their chosen places. There was not, so to speak, a great feeling of togetherness. At a point David Ben-Gurion, Israel’s founding father and first prime minister, was so disillusioned by the indifference of world Jewry that he went public with his criticism – not enough Jews were coming to live in Israel.
So how and why did the 1967 war transform the relationship between the Jews of the world and Israel? … continue
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