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.
NY Times Latest to Mislead Public on New Ivermectin Study
The NEJM study chose a much lower dose, 400mcg per day for only three days, less than half the total dose that has been shown to be effective
By Madhava Setty, M.D. | The Defender | March 31, 2022
The New York Times on Wednesday sent an email blast to subscribers with the subject line: “Breaking News: Ivermectin failed as a Covid treatment, a large clinical trial found.”
The Times was referring to a study I wrote about, that same day, for The Defender.
My article called out the Wall Street Journal for its March 18 reporting on the same study — before the study was even published — for its failure to provide an accurate, critical assessment of the study.
The study in question — “Effect of Early Treatment with Ivermectin among Patients with Covid-19” — was officially published Wednesday in the New England Journal of Medicine (NEJM).
In it the authors concluded:
“Treatment with ivermectin did not result in a lower incidence of medical admission to a hospital due to progression of Covid-19 or of prolonged emergency department observation among outpatients with an early diagnosis of Covid-19”
The Times did not critique the study itself, but quoted the opinion of Dr. David Boulware, an infectious-disease expert at the University of Minnesota:
“There’s really no sign of any benefit. Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin towards other therapies.”
Yes. Let us dive into the details and the data and see where it “steers” us, shall we?
A closer look at the details
The NEJM study took place in Brazil between March 23 and Aug. 6, 2021.
The study examined 1,358 people who expressed symptoms of COVID-19 at an outpatient care facility (within seven days of symptom onset), had a positive rapid test for the disease and had at least one of these risk factors for severe disease:
- Age over 50
- Hypertension requiring medical therapy
- Diabetes mellitus
- Cardiovascular disease
- Lung disease
- Smoking
- Obesity
- Organ transplantation
- Chronic kidney disease (stage IV) or receipt of dialysis
- Immunosuppressive therapy (receipt of ≥10 mg of prednisone or equivalent daily)
- Diagnosis of cancer within the previous 6 months
- Receipt of chemotherapy for cancer.
Young and healthy individuals were not part of this study.
Both vaccinated and unvaccinated individuals were included in the study. The percentage of vaccinated participants in each group was not specified. Note that by choosing not to identify vaccination status as a confounding variable the authors are implying that vaccines are playing no role in preventing hospitalization.
The 1,358 subjects were divided into two equally sized groups that were relatively well-matched and randomized to receive either a three-day dose of placebo or a three-day course of ivermectin at 400 mcg/kg.
The primary outcome was hospitalization due to COVID-19 within 28 days after randomization or an emergency department visit due to clinical worsening of COVID-19 (defined as the participant remaining under observation for >6 hours) within 28 days after randomization.
How researchers were able to conclude ‘no benefit’ despite signs to the contrary
The study’s authors wrote:
“100 patients (14.7%) in the ivermectin group had a primary-outcome event (composite of hospitalization due to the progression of COVID-19 or an emergency department visit of >6 hours that was due to clinical worsening of COVID-19), as compared with 111 (16.3%) in the placebo group (relative risk, 0.90; 95% Bayesian credible interval, 0.70 to 1.16).”
In other words, a greater percentage of placebo recipients required hospitalization or observation in an emergency department than those who received Ivermectin.
The authors of the study broke it down by subgroups here:
As is demonstrated in nearly every subgroup, the Ivermectin recipients fared better than those who received the placebo.
However, these data were not statistically significant given the size of the study.
This is how the authors were able to conclude there was no benefit to ivermectin use in preventing hospitalization in high-risk patients in their study.
Patients were under-dosed, some didn’t follow instructions
As it stands, the study The New York Times and The Wall Street Journal declared as proof of the uselessness of ivermectin in treating COVID-19 is actually quite promising — contrary to what their headlines told readers.
The dosing protocol advised by the Frontline COVID-19 Critical Care Alliance (FLCCC) includes a five-day course of ivermectin at 600 micrograms per kilogram of body weight for people with risk factors such as those possessed by participants in the study.
Instead, the investigators behind the NEJM study chose a much lower dose, 400mcg per day for only three days. This represents less than half of the total dose that has been shown to be effective in practice.
Furthermore, despite acknowledging that studies have shown some indication that the bioavailability of ivermectin increases when taken with food, especially a fatty meal, participants in the trial were instructed to take the medicine on an empty stomach.
In other words, the patients were significantly under-dosed — and yet a positive effect of the drug was emerging, though not statistically significant given the size of the study.
Also of note, the investigators chose to include emergency room visits with hospitalizations for COVID. Clearly, six hours of observation in an ER is a significantly different outcome than a hospitalization that may last a night or much longer.
When excluding the ER visits from the primary outcome and examining only hospitalizations, the ivermectin cohort had even less risk of an outcome, i.e. the relative risk was 0.84 vs 0.9 when ER visits and hospitalization were grouped together.
Perhaps the most glaring deficiency of the study is the low number of placebo recipients who actually followed the study’s protocol:
Only 288 of 679 participants randomized to receiving the placebo reported 100% adherence to the study protocol. Nearly 400 didn’t.
Why not? We asked Dr. Meryl Nass, an internist and member of the Children’s Health Defense scientific advisory committee.
Nass told The Defender :
“Presumably they knew the difference between ivermectin and placebo, and the placebo subjects went out and bought ivermectin or something else … but whatever they did, they didn’t bother with the pills they were given.
“So, it was not actually a double-blinded trial. Yet the 391 people who didn’t take the placebo but did something else were included in two of the three calculations of ivermectin efficacy anyway.”
So, was this the definitive answer proclaimed by mainstream sources? Nass thinks otherwise:
“I would say that instead, it was a failed trial due to the 391 placebo recipients who admitted they did not follow protocol versus the 55 in the ivermectin arm.”
More questions than answers
Rather than pounding the final nail in the coffin around ivermectin’s utility in treating COVID, the NEJM study raises more questions.
- What would the effect have been if a higher dose shown to be effective were administered?
- What would be the benefit of this medicine in patients with no risk factors?
- How statistically significant would the results have been if more participants were enrolled?
- Why weren’t more participants enrolled as the study progressed given the emerging benefit of the drug and the absence of adverse events?
- Why did the investigators define a primary outcome with such different real-world implications (ER visits vs hospitalizations)?
- With less than 50% of the placebo arm adhering to the study protocol, why were their outcomes included in the analysis?
- What effect did vaccination status have on outcome? If this is the primary means endorsed to prevent hospitalization, why wasn’t vaccination status mentioned as a confounder?
- Did the investigators choose to limit the study as it became clear that an Ivermectin benefit would be too big to ignore?
Given these obvious issues with the study, it is becoming even more clear where the real story is: Neither The Wall Street Journal or The New York Times are willing to pursue startling details around how corporate interests are corrupting scientific opinion as reported here.
Instead, these iconic journals chose to report on a scientific study on or prior to the day of publication using misleading headlines backed up by flimsy investigations conducted by journalists with no capacity to dissect the analysis or data.
Here’s a bigger question: Are they incompetent, or complicit, too?
© 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.
Featured Video
My would-be assassins are still in office – former Pakistani PM
or go to
Aletho News Archives – Video-Images
From the Archives
Nine Covid Facts: A Pandemic of Fearmongering and Ignorance
By Jeff Harris | Ron Paul Institute | October 28, 2020
Ever since the alleged pandemic erupted this past March the mainstream media has spewed a non-stop stream of misinformation that appears to be laser focused on generating maximum fear among the citizenry. But the facts and the science simply don’t support the grave picture painted of a deadly virus sweeping the land.
Yes we do have a pandemic, but it’ a pandemic of ginned up pseudo-science masquerading as unbiased fact. Here are nine facts backed up with data, in many cases from the CDC itself that paints a very different picture from the fear and dread being relentlessly drummed into the brains of unsuspecting citizens. … continue
Blog Roll
Recent Comments
Aletho News- What you need to know about Russia-China relations, but were afraid to ask March 26, 2023
- Xi’s ‘Chilling’ Remarks: A Multipolar World Offers Challenges and Opportunities to the Middle East and Africa March 26, 2023
- US is stirring up the Syrian cauldron March 26, 2023
- Will Pakistan Support A US Mercenary’s Plot To Recruit Afghan Refugees As Fighters For Kiev? March 26, 2023
- No, We Don’t Need More Nuclear Weapons March 26, 2023
- The Cult of the Climate Apocalypse March 26, 2023
- The Cell Phone Is a Pair of Red High Heels March 26, 2023
- Climate-Neutral Already By 2030?… Berliners To Vote On Climate-Neutrality Referendum Today! March 26, 2023
- Guardian Pushes Alarmist Claim That Climate Change Threatens Coffee Production as Yields Soar March 26, 2023
- My would-be assassins are still in office – former Pakistani PM March 26, 2023
- Twenty Times the CDC Exaggerated the Threat From Covid With False Data March 26, 2023
- Russia Foreign Ministry calls for prosecuting Israelis responsible for Church of Gethsemane attack March 25, 2023
- Putin: West’s Weapons Supply to Ukraine Won’t Be Enough to Outgun Russia March 25, 2023
- Fake News Alert: Chinese “Patriots” Don’t Want To Retake Russia’s Far East March 25, 2023
- Zelensky Admitted That Ukraine Already Ran Out Of Ammo March 25, 2023
- Hungary comments on Ukraine’s NATO and EU bids March 25, 2023
- ‘Bring Our Troops Home’: Matt Gaetz, Rand Paul Repeat Call for Syria Pullout Amid New Attacks March 25, 2023
- TOP GERMAN HEALTH OFFICIAL LAUTERBACH FOLDS ON VACCINE INJURIES March 25, 2023
- If Americans Knew
- Brownstone Institute
- My Testimony on Texas State Senate HHS Bills March 26, 2023
- FDA Is Wrong Again: Mailed Abortion Drugs are Not Safe March 25, 2023
- The DOD Plays Hardball with Covid Vaccinations March 24, 2023
- Madness in the Law Schools March 24, 2023
- How They Convinced Trump to Lock Down March 23, 2023
- The Lab Leak and the Counter Measures: What Really Happened March 23, 2023
- Richie Allen
- Bordeaux Town Hall Burnt Down By Pension Reform Protesters March 24, 2023
- Scottish Schools Tell Kids There Are THREE Biological Sexes March 24, 2023
- Greta Thunberg To Sue Sweden For Climate Change Inaction March 23, 2023
- USA Today Names BLOKE In WOMEN Of The Year List March 23, 2023
- Not A Lot Of People Know That
- Energy Industries Club speech on energy security March 26, 2023
- Climate Change Is “Bigger Existential Threat Than Nuclear War” , Says Nutty Sustainability Advisor March 26, 2023
- Will Offshore Wind Lower Energy Bills? March 25, 2023
- Germany Rebels Against EU Ban On Petrol Cars March 24, 2023
- No Tricks Zone
- Consent Factory
- The Censorship Industrial Complex March 10, 2023
Aletho News 