In a move that frontline physicians across the country believe may bring about a turning point in the pandemic, the National Institutes of Health (NIH) last week revised its guidelines on ivermectin (IVM), making the anti-parasitic “wonder” drug an option for treatment of Covid-19.
The federal agency’s shift from opposition to “neither-for-or-against” was widely applauded by frontline doctors battling Covid.
Ivermectin is already approved by the FDA and is on the World Health Organization’s list of model list of essential medicines. But the federal agency had until now advised against its use for Covid-19 outside of a hospital setting or clinical trial. The agency’s website now informs viewers that the NIH is neutral on the subject.
“The Treatment Guidelines Panel “has determined that currently there are insufficient data to recommend either for or against the use of ivermectin for the treatment of COVID-19,” the website says.
The new NIH recommendations mirror the agency’s upgraded policies toward monoclonal antibody infusion (blood plasma) and corticosteroids, treatment options that were previously opposed by the NIH but now widely used to treat Covid patients across the nation.
“We are encouraged that the NIH has moved off of its August 27 recommendation against the use of ivermectin,” said pulmonologist and ICU specialist Dr. Pierre Kory, president of Frontline Covid Critical Care (FLCCC). “That recommendation was outdated. It was made just as the numerous compelling studies for ivermectin were starting to roll in.”
“Ivermectin is proving to be a wonder drug, an immensely powerful anti-viral and anti-inflammatory agent,” he told a Senate panel in November in a presentation by FLCCC.
Kory referenced an online meta-analysis of over 50 studies on ivermectin studies performed across the world, summarized online in 19study.com. One hundred percent of the studies testify to the effectiveness of early Covid treatment and prophylaxis with ivermectin, he said.
Developed in 1975, the drug is an “old friend” in many countries. It has led to the eradication of a “pandemic” of parasitic diseases including ringworm, river blindness and head lice across multiple continents. In 2015 it earned the Nobel Prize for Medicine for its discoverers, Dr. William Campbell and Dr. Omura Satoshi.
The data shows the drug acts as a prophylaxis (preventive) in preventing Covid-19 infection; it keeps those with early symptoms from progressing to the hyper-inflammatory phase of the disease and even helps critically ill patients recover,” Dr. Kory told the Senate committee.
As Covid deaths continue to soar in many parts of the country, the NIH’s changed policy toward ivermectin is expected to translate into profound ramifications for the public.
Doctors who believe in the drug’s efficacy in keeping patients with mild or no symptoms out of the hospital, can now prescribe it without fear of harassment and legal repercussions. Severely ill Covid patients will not feel their lives are further imperiled by the senseless withholding of much needed medication.
The shift in the NIH policy came after a meeting its Treatment Guidelines Panel held with doctors from FLCCC two weeks ago. The physicians were invited to present the four months of medical findings on ivermectin that have made headlines in medical circles since the agency last issued its guidelines almost five months ago.
During the meeting, Dr. Pierre Kory, Dr. Paul Marik and Dr. Andrew Hill from the University of Liverpool pressed the NIH to reevaluate its negative stance on ivermectin.
The doctors updated the panel on the dozens of clinical studies that showed significant benefits of ivermectin in prophylaxis, early treatment and also in late-stage Covid. The evidence encompassed 18 peer-reviewed randomized controlled trials (RCT’s) that included over 2100 Covid patients.
The trial results demonstrated that ivermectin produces faster viral clearance, faster time to hospital discharge, faster time to clinical recovery, and a 75% reduction in mortality rates, as compared with other treatments and non-treatment.
The physicians called on the NIH to prevent needless deaths by immediately updating their guidelines to reflect the strength of the data supporting ivermectin in all stages of Covid disease.
A week later, the NIH issued its revised statements concerning ivermection, effectively removing legal roadblocks toward its usage even without an official Emergency Use Authorization (EAU).
Doctors hailed the move as a significant breakthrough after months of trying to disseminate awareness of ivermectin, together with other drugs, as a potential game-changers in the battle against Covid. The campaign had failed to achieve real traction until it received a considerable boost at two Senate Hearings convened in May and November on the topic of Early Outpatient Treatment: An Essential Part of a COVID-19 Solution.”
The hearings, initiated by Sen. Ron Johnson, R-Wis., brought almost a dozen experts from across the country to address how early at-home treatment with ivermectin together with other FDA-approved drugs can potentially end the pandemic. The hearings raised the profile of dedicated physicians whose voices were being marginalized by a hostile media, and carried their vital message about early treatment for Covid-19 to the broader community.
‘People of Color, the Elderly and the Poor’
At the November Senate hearing, the doctors called for federal health agencies to abandon the “go-home-quarantine-and-wait-it-out” policy toward Covid-19 patients, and to adopt a proactive approach to killing the virus in the early stage, with drugs that are widely available, safe and cheap.
The NIH came in for scathing criticism at the Senate hearing.
“Astonishingly, the National Institutes of Health, in its October 2020 Treatment Guidelines, directs doctors to let even high-risk Covid-19 patients sicken at home for two weeks or more, and when finally gasping and choking for air, place them in hospital isolation,” testified Dr. Peter McCullough, vice chief of medicine at Baylor University Medical Center in Dallas.
While the NIH, agency representatives, and academicians stand behind this document as “best science,” many practicing physicians, patients, and community leaders view this as medically irresponsible and unconscionable,” the doctor said.
Frontline doctors working at the patients’ bedside deplore the do-nothing-until-you’re-in-crisis approach.
“People are dying needlessly at untold rates. As a lung and ICU specialist, all I do right now is take care of Covid patients dying of breathlessness in ICUs,” Dr. Pierre Kory told the Senate panel. “By the time they get to the ICU, their lungs cannot draw in air. They simply cannot breathe. Even with ventilator masks and oxygen delivery devices, most ICU patients do not make it.”
Kory shared his experience that most of the deaths he witnessed were among the most vulnerable members of the population, “the elderly and the poor as well as people of color in many communities.” The way the pandemic has struck these populations so heavily “is tragic, the greatest disparity” he has ever witnessed, he said. The people, particularly, are in dire need of early intervention when Covid infection sets in.
Harvard-trained Dr. George Fareed, addressing the Senate hearing in November, described his experience in the Imperial Valley “that became the Covid epicenter for California” in June and July 2020.
“Both in my Brawley clinic and in Valley Urgent Care Clinic in El Centro where I also work, over 25,000 fearful people were screened. Of those, over two thousand four hundred were Covid-19 positive,” he said.
“We treated successfully many hundreds of the high risk and symptomatic patients,” Dr. Fareed testified, noting that he uses a triple HCQ cocktail: HCQ (3200 mg over 5 days), ivermectin, azithromycin or doxycycline and zinc aimed at disrupting viral replication.
Vitamins C and D as well as Quercetin, anti-coagulants and corticosteroids such as dexamethasone and prednisone further “reduce the risk of escalation to cytokine storm and blood-clotting,” he said.
“The multi-drug cocktail is best given early within the first 5 to 7 days while the patient is in the flu stage. I use it especially in high risk individuals, anyone over 60 or with co-morbidities, and anyone with moderate to severe flu symptoms,” Dr. Fareed explained.
“I used this regimen to successfully treat 31 elderly nursing home residents in an outbreak in June. 29 recovered fully,” he added.
“The science tells us that early treatment would be an effective strategy to use on a national level,” Farred said. “This realization motivated me and a few of my colleagues to write a letter to the President, a letter to my congressman, a letter to California health department, an Open Letter to Dr. Fauci, and a National Plan for Covid-19.
“As we describe in the National Plan, this approach would be the solution to the pandemic; protect the vulnerable, and if high risk individuals get sick, there is a solution for them as well—early treatment with the antiviral cocktail.”
It bears noting that HCQ has not been included in the NIH’s “upgrades” on Covid treatments although it continues to be re-purposed as a frontline Covid treatment in many parts of the world.
Despite voluminous evidence of its safety and efficacy by leading experts, including FLCCC physicians at the May and November Senate hearings, government health agencies have consistently blocked the drug’s release from national stockpiles.
Delaying Treatment Can Be Disastrous
“This is a very insidious disease and as we’ve seen, it can progress to deadly levels with no explanation,” Dr. Peter McCullough of Baylor University Medical Center Hospital in Dallas, stressed at the Senate hearing. “The idea of not treating it until a patient gets to the hospital does not make sense.”
“Unlike the flu or viruses that caused previous pandemics, Covid-19 can lead to three distinct, lethal outcomes: viral damage to organs, cytokine storm, and micro-thrombosis (blood clots). The mortality curve can reach 30 days [after infection],” Dr. McCullough noted.
“Patients wait in fear at home after testing positive, logically thinking they would face a terrifying hospitalization, isolation, and at worse–death. But delayed treatment for many can be disastrous. Early home treatment is the answer. The hospital should only be a safety net for survival. It should not be the first place of treatment.”
“The United States would be wise to follow what India and Brazil have done and make available at-home Covid-19 treatment kits containing dosages of ivermectin, HCQ and key vitamin supplements,” Dr. McCullough urged. “Why should someone getting infected in the United States have a greater chance of dying from the disease, than a citizen of poorer countries who has access to early treatment?”
McCullough urged the Senate committee “to ask all responsible government agencies to prioritize an early treatment initiative. Competent physicians should be supported by all stakeholders in their efforts to provide patients with compassionate care, reduce the spread of infection, and avoid hospitalization and death,” he said.
“I believe this is the only viable strategy to avoid catastrophic loss of life before natural immunity and vaccination can bring this crisis to a close,” he concluded.
‘The Virus is Easy to Kill’
Renowned gastroenterologist Dr. Thomas Borody, medical director of Australia’s Center for Digestive Disease, was one of the first experts calling for ivermectin to be used for Covid treatment as early as last August.
Borody who is credited with developing a triple therapy that eradicates peptic ulcers once thought to be incurable, has joined forces with California researcher Dr. Sabine Hazan, founder of Ventura Clinical Trials, to create a protocol for Covid treatment.
“Studies on ivermectin show amazing success–clear and statistically significant benefits for pre-exposure and post-exposure prophylaxis, as well as effectively reducing mortality in early and late disease phases,” Barody said in a televised interview on Sky News.
“The virus is surprisingly easy to kill,” he said.
Borody said an ivermectin tablet could cost as little as $2, which is likely why drug makers haven’t promoted the drug’s usage. He also suggested that having a relatively easy way to wipe out the disease would drastically reduce hospitalizations which in turn would sharply cut industry profits. Not everyone is going to be happy about that, which is perhaps why the establishment continues to ignore outpatient Covid remedies.
Doctors can’t get government health agencies to even look at the medical data, Dr. Borody said, noting that his effort to alert his own government to the “powerful activity of ivermectin against the virus on the intercellular level” was met with silence.
“Neither the United States or Australia have a curative program for Covid-19. It’s all about lockdowns and vaccines,” he said. The vaccine has benefits but as its proponents admit, “it does not cure the disease or prevent its transmission. Ivermectin does both.”
Some have noted that the vaccine was issued with an Emergency Use Authorization (EUA), which falls short of full FDA approval as its long-term safety has not yet been assured. According to the law, the EUA remains valid only as long as no other safe, effective medical alternative exists.
Could Ivermectin’s potential success in eradicating Covid be seen as reducing the need for a vaccine, Dr. Borody was asked in an interview. He dismissed this notion, saying both options are vital. “The guiding principle is to use all available means to save lives now. To end the pandemic we must treat and vaccinate, treat and vaccinate.”
TIMING IS EVERYTHING
Sen. Josh Hawley, R-Mo, Questions Dr. George Fareed at Senate Hearing
Sen. Hawley: In your testimony, Dr. Fareed, you say that “timing is everything” when it comes to treatment for Covid-19. And that the best time for outpatient treatment to prevent hospitalization is when “the virus is in a period of maximum replication in the upper respiratory tract.” Can you explain what this would mean for a patient? Would this be five days after exposure, or ten days? Or is it based on symptoms?
Dr. Fareed: The earlier the treatment can be started after the start of infection, the more rapid the recovery, and the more reduced the risk of transmission. Symptoms typically start within 1-4 days of viral entry into the upper respiratory system, and that is the optimal time to start treatment.
Sen. Hawley: In your experience, are patients typically coming in to get treated at this point in their illness? And if not, what do you think we need to do to encourage high-risk individuals to seek outpatient treatment and care?
Dr. Fareed: More patients are coming in to get treated or contacting me from afar for treatment when they can’t receive treatment in their local communities. Sadly, many infected people as well as primary care and ER doctors follow NIH guidance, which is to offer no early treatment. We need that to change. The NIH/FDA/CDC need to formally acknowledge the importance of early treatment with safe anti-virals and other meds so readily available.
When that happens, everything will improve dramatically.
Judge Orders Hospital to Administer Ivermectin to Critically Ill Patient
In a remarkable story reported this week by The Buffalo News, a NY supreme court judge ordered a hospital to administer ivermectin to an 80-year old Covid-19 patient in critical condition, after doctors refused the family’s pleas to give her the medication.
“This lady was on a ventilator, literally on her deathbed, before she was given this drug,” related the family’s attorney, Ralph Lorigo.
Judith Smentiewicz was taken by ambulance in late December to Millard Fillmore Suburban Hospital and immediately hooked up to a ventilator. The ICU doctors informed her son, Michael, that her chance of survival was about 20 per cent, and that she might linger on the ventilator for at least a month.
“We did a lot of our own research, we read about Ivermectin … The results sounded very promising, and we decided we had to try it,” Michael Smentkiewicz said. “We pressured the doctor in the ICU to give it to her. He finally agreed.
The elderly patient was given her first dose of Ivermectin and a few days later, according to court papers later filed by her family, she made “a complete turnaround.”
“In less than 48 hours, my mother was taken off the ventilator, transferred out of the Intensive Care Unit, sitting up on her own and communicating,” daughter Michelle Kulbacki said in a court affidavit.
But her mother’s progress came to a sudden halt after she was transferred out of the ICU to another hospital wing. Doctors in that unit refused to give her Ivermectin and her condition quickly worsened, the article reported.
“We were astounded when they refused to give her any more of the drug,” Michael Smentkiewicz said. “That’s why I called Ralph Lorigo and we took the hospital to court.”
Kaleida Health, which operates the hospital, opposed the family’s request in court, arguing before Judge Henry Nowak that doctors – and not the courts – should be making decisions about medical care.
While the case was being deliberated, the family tried to think of what else they could do.
“We had not been able to see my mother since she was taken to the hospital by ambulance, and that’s been hard on all of us,” Smentkiewicz said. “Family flew in from all over the country to be here. About eight of us held a little prayer service for her, out in the hospital parking lot. Even though we couldn’t be with her, we felt that it was important to be on that property, praying for her.”
A few days later, Judge Nowak ordered the hospital to “immediately administer the drug Ivermectin to patient Judith Smentkiewicz,” court papers show.
Once ivermectin treatments resumed, the patient’s condition again improved, the family related. “My mom called me the other night. Her voice was raspy, but it was so exciting to hear her voice,” her son shared with the Buffalo News reporter. “She’s sitting up in bed. She’s off the ventilator but has a cannula in her nose providing supplemental oxygen.”
He added that a doctor from the hospital told him the following day that his mother appeared to have “turned the corner” in her fight against the virus.
The family said they believe a “miracle drug called ivermectin” combined with the power of prayer saved their mother’s life.