THE NIH ADMITS IT: Ivermectin has a place in the treatment of Covid-19
Commentary by Patrice Greanville
NOTE: In this medical news section we try to give our readers information about interesting and promising developments on the fight against major diseases, but readers must keep in mind that we are often forced to publish materials originating within the US-style capitalist healthcare industry in which profits and not wellness is the main driver for action or inaction.
Editor's Note: Our readers know that, by and large, the US medical establishment and its Big Pharma arm, are highly compromised due to the capture of political, regulatory and research institutions by corporate interests. This, of course, applies not only to Congress and state politicians, a crowd already well known for their astonishing venality, but to the NIH, the FDA, and other critical US government institutions responsible for the health of all US citizens. Indeed, the Covid pandemic has provided the American nation with a stern lesson about the wrongheadedness, nay, crime, of allowing profits to rule the nation's medical decisions. In this context, we have witnessed (and still do), Big Pharma's aggressive meddling to control the extremely lucrative production and approval (in record time) of drugs and modalities to handle the SARS-CoV-2 coronavirus (which, as we know, causes COVID-19), with practically no legal liability, the latter a highly unusual provision guaranteed by the US government, which has also exerted its influence on behalf of certain players such as Pfizer to ensure that even the WHO would follow global guidelines benefiting this firm and its associates. As a result, strange things have characterised this global emergency. We'll leave the contentious origins of Covid-19 for another discussion, although we suspect that Covid came into being as a misfire (?) in the development of "ethnoweapons", a form of biowarfare targeting specific nationalities, races, etc., currently prohibited by international treaties such as the Geneva Protocol. The US is supposed to have ended its program in 1969, but this is a field in which the US military—given a bloated budget that affords it to leave no technology untouched—is strongly suspected to engage. During the Ukraine war, and to Washington's embarrassment, advancing Russian troops discovered more than a dozen US-funded biolabs apparently involved in this type of sordid research. Along with the pharmaceutical industry, a key component these days of global capitalism, the pandemic also gave other sectors of the US ruling elite excuses to institute dubious policies and rules, such as massive lockdowns, (useful in future mass pacification campaigns), all in the name of safeguarding the nation's health. One of the most bizarre and controversial phenomena (albeit with little of this controversy reflected in the mass media) has been the rapid erosion of standard medical ethics and long-accepted practices, with virtually no serious discussion in professional circles and institutions, nor peer reviews. Indeed, the protocols to treat patients were suddenly upended, and while actual therapies were denied or put aside, the public was herded into accepting the notion that a new "vaccine" —which is formally a preventative—should be exclusively used. Further, and compounding this curious shift, we also saw an unjustifiable delay in the treatment of patients with known and effective antiviral drugs such as Ivermectin—a low-cost (it's a generic), widely used and well-known drug, and the subject of an all-out defamation campaign by Big Pharma, especially Pfizer—that could have prevented a substantial number of deaths in patients being treated with other dubious pharmacological options. Equally disturbing, many patients in the US and worldwide were admitted to ICUs showing signs of respiratory failure due to Covid's more dangerous inflammatory phase but denied proven antivirals like Ivermectin, using instead chiefly compensatory invasive mechanical ventilation with a high mortality rate. (See, for example, ICU and ventilator mortality among critically ill adults with COVID-19, and draw your own conclusions. The paper admits alarmingly high mortality rates among patients hooked to ventilators, even among the best cohorts examined, but still defends the practice of aggressive ventilation without showing enough data nor providing an adequate discussion of whether effective antivirals had been used or not instead of just mRNA vaccines). That said, while ventilators do save lives under certain circumstances, as an expert reminds us, being put on a ventilator is a serious matter: "When using a ventilator, you may need to stay in bed or use a wheelchair. This raises your risk of blood clots, serious wounds on your skin called bedsores, and infections. Fluid can build up in the air sacs inside your lungs, which are usually filled with air. This is called pulmonary edema..." The NIH has a helpful paper on this topic. See Risks of Being on a Ventilator (Last updated on March 24, 2022.) The record shows that the entire medical and political establishment, supported by a revoltingly complicit media (an instance in which the normally subterranean "Censorship Industrial Complex", set up to supposedly fight disinformation, was first deployed en masse), embarked on practices of such cost, unconstitutionality, and mediocre-to-poor results, that the whole thing may eventually obligate an extensive formal inquiry. Meanwhile, to defend the narrative favoring Big Pharma and the complicit NIH and FDA—as good an example of a captive agency as they come— dozens of reputations were tarnished. Many highly qualified and ethical doctors such as Dr Robert Malone, who objected to the corporate-government alliance's handling of the pandemic, were simply defamed or rendered invisible. Just observe this infamous stab by none other than our paper of record. If anyone needs an example of why liberal authoritarianism is both underhanded and repellent, this piece on the New York Times will do just fine.
In this ongoing mess, some corporations and their circles of influence played a singularly nefarious role. Pfizer, in particular, stands out for its outsize greed and lack of an ethical conscience in an industry where outrageously exploitative behavior is the norm. Its malignant footprint, which has even attracted the attention of corrupt entities such as the EU, includes not just the wholesale and often high-handed bribery of the US political and medical establishments, but, through a gigantic advertising budget, the mass media themselves, which, as commercial entities, put profits, too, above the public interest. Incidentally, do note that while the value of Ivermectin is well established in all phases of Covid treatment, the author(s) chose to suggest restricted use to only its "mild" stages, or relegation to a distant, purely secondary role in the presence of supposedly more modern and powerful antiviral agents. This is totally wrong, and prejudicial against Ivermectin, but the upshot is that most doctors, especially those working at large group practices that operate like (and often are part of) some much larger Wall Street conglomerate, refuse to include it in their formularies. As usual, this is America, where conformity rules and nobody wants to make waves. —PG |
The paper below was published by the NIH, a US-taxpayer-funded public health entity. As such it belongs to all US citizens.
Does ivermectin have a place in the treatment of mild Covid-19?
Does ivermectin have a place in the treatment of mild Covid-19?
Ivermectin has been used to treat humans for the past 4 decades. It was approved as a broad-spectrum anti-parasitic agent, initially indicated in 1987 to treat onchocerciasis and was given as a mass drug administration (MDA) in endemic countries. Its success awarded the discoverers the Nobel prize of Medicine in 2015. Ivermectin's principal activity was to treat infections caused by roundworm parasites. Over the years, the spectrum was broadened to include ectoparasites such as scabies among others. Through the years more than 3 billion doses have been given to humans (not to horses) with a high safety profile, and the drug was added to the World Health Organization's List of Essential Medicines [https://apps.who.int/iris/bitstream/handle/10665/345533/WHO-MHP-HPS-EML-2021.02-eng.pdf ].
In the last decade, several in-vitro studies have shown its anti-viral activity against a broad range of viruses. At the beginning of the COVID pandemic, ivermectin was tested in vitro against SARS-CoV-2 and showed a highly significant reduction (99.8%) in viral RNA after 48 hours [1], but it was criticized that this was achieved by using a much higher dose in comparison to the standard dose in human use [2]. However, its anti-COVID activity in real-life in patients who were treated with standard dose of 3 days of ivermectin showed the significant reduction in culture viability in the ivermectin group compared to placebo [3]. In addition, ivermectin has anti-inflammatory properties based on in-vitro and in animal model studies. An extensive review of the potential mechanisms of action for ivermectin against COVID-19 was recently published [4].
SARS-CoV-2 infection includes several stages, where the initial stage is manifested by high viral replication followed by the second stage (occurring in the high risk groups mainly) of excessive inflammatory response causing severe disease and death. Therefore, ivermectin may have a dual role in this infection, acting as both an anti-viral and anti-inflammatory agent. With its high safety profile, ivermectin is a potential treatment against COVID-19 in its different stages.
There are already over 80 studies assessing the impact of the drug in the different stages of the disease such as: preventing infection, shortening viral shedding, preventing hospitalization, and death and more [https://ivmmeta.com]. Several reviews and meta-analyses disputing the value of this drug in fighting the COVID pandemic were published with the main argument against using ivermectin being that the level of existing evidence for its positive effect is based mainly on studies lacking a high standard of rigorous methodology [5,6]. One must also consider however that since the drug no longer has rights for patent, pharmaceutical companies have no monetary incentive to conduct clinical trials using this medication, and governmental agencies are reluctant to sponsor trials for drug repurposing.
Efforts have been made to identify high quality studies in order to come to consensus [5]. In regard to reduced hospitalization for patients receiving the drug at the early stage of the disease, three studies were identified by Hill et al. [3,7,8]. Combing the results of these three studies, with the recent TOGETHER trial in Brazil [9], there has been shown a significant reduction in hospitalization, with risk ratio of 0.74 (p = 0.02) [see Fig. 1]. In all studies patients were recruited within 7 days from symptom onset (at a median of 4-5 days).
The introduction of COVID 19 vaccines was a game changer in fighting the pandemic. However, it has become clear that we cannot rely on vaccines as a sole agent in this battle. The phenomena of waning immunity within several months, the viral mutations which can elude the virus from vaccine efficacy, all highlight the need for anti-viral drugs to prevent deterioration, hospitalization and death. In fact even the big vaccine/pharma companies have entered the race of finding an efficient anti-COVID drug.
In addition to the repurposed-drug ivermectin mentioned above, the first new drug to show anti-COVID activity was molnupiravir (manufactured by Merck). It initially demonstrated a 50% reduction in hospitalization in high-risk groups but in final analysis, unfortunately showed only a 30% decrease in hospitalization [10].
The second new drug was nirmatrelvir, which given together with ritonavir under the brand name paxlovid (manufactured by Pfizer), showed an 89% reduction in hospitalization [11]. The main disadvantage of paxlovid is the potential and serious interactions with a long list of medications and it is also contraindicated for use in those with certain medical conditions. Unfortunately these are often the patients with co-morbidities, on a chronic medication regime who are in need of this drug. Another drawback of these two drugs is the fact that they should be administered within five days of symptom onset, and the treatment course costs several hundreds USD.
Both drugs (paxlovid and molnupiravir) were received an emergency use authorization by the FDA, and were authorized to be used by health authorities in many countries. So far there have been no published post-marketing field studies looking at the real-life results of their efficacy in preventing hospitalization, death as well as the actual profile of their adverse-events. In addition, unpublished data by Pfizer about paxlovid efficacy in mixed populations of vaccinated and non-vaccinated patients (who are the current candidates for therapy these days), showed that the drug did not reach a significant advantage over placebo [12].
So, is there a role for ivermectin early treatment in an era when we have new anti-COVID drugs?
Comparing molnupiravir to ivermectin in preventing hospitalization [Table 1], we see that based on existing data the performance of ivermectin is similar to molnupiravir. Furthermore, ivermectin has a good safety-profile in terms of adverse events, and in addition the cost is in order of 100 times less when compared to the newer drugs. In addition, ivermectin is easily available in most countries, an important fact especially in low-middle-income countries where getting these newer and expensive drugs may not be feasible. Accordingly, in countries where the two new medications (paxlovid and molnupiravir) are not available, ivermectin should be offered.
Table 1
Drug (Ref) | Ivermectin [3,[7], [8], [9]] | Molnupiravir [10] |
---|---|---|
Total number of participants | 2346 Drug- 1079/Placebo-1044 |
1408 Drug-709/Placebo-699 |
% High Risk | Any co-morbidity = ∼75% | All |
% positive in Placebo arm | 129/1170 = 12.3% | 68/699 = 9.7% |
% positive in active drug arm | 98/1176 = 9.0% | 48/709 = 6.8% |
Risk Ratio (95% CI) | 0.74 (0.58-0.94) | 0.69 (0.48 to 1.01) |
P-value | 0.02 | 0.04 |
Even in high-income countries where these two drugs might be available, there remains a role for ivermectin. Data from MOH in Israel show that only the minority (about 10%-15%) of high-risk patients are actually getting treatment. This is due to the limited supply of these drugs, the hesitancy to take these drugs related to fear of their unknown adverse events or to known contraindications in using them. Therefore offering them ivermectin should be a viable option.
Since in most countries ivermectin has not been approved for COVID treatment, performing ivermectin vs. placebo studies appears to be unethical when these two newer drugs have been officially approved by health-authorities. However, offering ivermectin to those who refuse the new drugs seems to be a reasonable option. Since eligibility criteria in getting these early treatments are targeted to high-risk patients only (although the definition of high risk might differ from one country to the other), observing the outcome of these arms of treatment: paxlovid vs. molnupiravir vs. ivermectin might shed light on the value of ivermectin in comparison to the newer drugs. Since, undoubtedly there will be patients who will refuse any treatment, they in fact can serve as a control arm receiving SOC (standard of care). Although COVID regulations are loosening, the pandemic is still circulating and therefore this suggested prospective observational study is still highly important and timely, and potentially will give us the value of each treatment arm.
References
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